Alkaline phosphatase must be within the range allowing for eligibility, must be obtained < 2 weeks prior to randomization
Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization following surgery
Other baseline laboratory evaluations, listed in Section 6.0, must be done within 14 days prior to randomization.
Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to randomization
Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
Patients must be adequately recovered from surgery at the time of randomization
INTRA-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIA
POST-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIA
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): No specific timeframe between registration and randomization needs to be observed, as long as:\r\n* Patients randomized to the chemotherapy arms have their cycle 1/ day 1 (platinum based or capecitabine) start within 3 weeks (15 working days) following randomization date\r\n* Randomization occurs no more than 24 weeks from surgery date
Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization
Patients must have measurable or non-measurable stage III/locally advanced or metastatic carcinoma of the breast where local therapy with curative intent is not possible; lesions must be evaluated =< 4 weeks prior to study randomization; diagnostic-quality computed tomography (CT) scans with both oral and intravenous (IV) contrast are the expected radiologic method, unless an alternative is approved\r\n* NOTE: Where baseline imaging has already been performed =< 6 weeks prior to study randomization, repeat imaging may not be required
Patients may not have received any of the protocol agents within 5 years prior to randomization
Patients must have specimens submitted for FLT3 testing for randomization stratification; collection of pretreatment specimens must be completed within 1 day of registration to Step 1; specimens must be submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System; FLT3 results will be used for stratification purposes at the time of randomization; E-mail notification of randomization assignment must be received prior to Step 2 registration
Patients receiving systemic chemotherapy within 3 weeks prior to randomization
Serum creatinine < 1.5 x ULN; the values must be obtained within 48 hours prior to randomization
Hemoglobin >= 9.0 g/L within 4 weeks before randomization
Prior treatment with oxaliplatin chemotherapy within 6 months prior to randomization
Preoperative biopsy for confirmation of renal cell carcinoma (RCC) must be performed within four (4) months prior to randomization\r\n* If biopsy was performed as part of patients standard care, and will not be performed during step 0 proceed directly to randomization
Impending need for palliative RT or surgery for pathological fractures and/or for medullary compression within four weeks prior to randomization.
Severe infection within 4 weeks prior to randomization
RBC transfusion of either 2-4 pRBC units over the 8 weeks prior to randomization or 1 pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to randomization
ESA use of less than 28 days and no ESA within the 12 weeks prior to randomization
Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within 3 weeks (6 weeks for nitrosoureas) prior to randomization. IMiDs, PIs and or corticosteroids within 2 weeks prior to randomization. Other investigational therapies and monoclonal antibodies within 4 weeks of randomization. Prednisone up to but no more than 10 mg orally q.d. or its equivalent for symptom management of comorbid conditions is permitted but dose should be stable for at least 7 days prior to randomization
Severe infection within 4 weeks prior to randomization
A serum TSH and AM cortisol must be obtained within 28 days prior to randomization to obtain a baseline value.
Pregnancy or lactation at the time of randomization or intention to become pregnant during the study. (Note: Negative serum pregnancy test must be obtained within 14 days prior to randomization).
Last dose of AZA or DAC within 6 months before the planned date of randomization; however, must be off these treatments for ? 4 weeks before randomization
Investigational therapy within 4 weeks of planned randomization
Participants with clinically diagnosed moderate to severe cGvHD according to NIH Consensus Criteria prior to randomization:
Use of 5-alpha reductase inhibitor within 42 days prior to randomization
Patient has adequate biological parameters as demonstrated by the following blood counts at baseline (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization):
Patient has the following blood chemistry levels at baseline (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization):
Patient has no clinically significant abnormalities on urinalysis results (obtained < 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed < 14 days prior to randomization).
Baseline laboratory evaluations must be done within 14 days prior to randomization and some must be repeated < 72 hours prior to randomization.
Patient has a > 20% decrease in serum albumin level between Baseline visit and within 72 hours prior to randomization.
Patient has a > 10% decrease in weight between Baseline visit and within 72 hours prior to randomization.
Patient may have prior salvage therapy (surgery, radiation or other local ablative procedures) within 6 months prior to randomization if the intent was for cure; prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed
Radiation therapy within prior 6 months (prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed)
Agree to be evaluated at the transplant center or by local provider every 3 months for 12 months after randomization
Grade >= 3 hemorrhage within 4 weeks of patient randomization
Started antiandrogen therapy (ADT) no longer than 6 months prior to randomization
Received ADT for more than 6 months prior to randomization
History of intracranial abscess within 6 months prior to randomization.
Must have undergone a nephrectomy and/or metastasectomy ?28 days prior to signing informed consent and ?12 weeks prior to randomization.
Has had major surgery, other than nephrectomy and/or resection of pre-existing metastases for M1 NED participants, within 12 weeks prior to randomization.
Demonstrate adequate organ function obtained within 14 days prior to randomization and analyzed by the central laboratory.
Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.
For females, documentation that the participant is being followed with cervical cytology and/or HPV testing per current “Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents” and American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines; cervical cytology must be performed prior to randomization for women who are overdue for screening per the guidelines; women should also have confirmation of absence of cancer or suspected cancer upon visual examination of the vulva, vagina, and cervix within 12 months prior to randomization
Androgens such as testosterone, dehydroepiandrosterone (DHEA), etc. unless discontinued at least two weeks prior to randomization.
Tumor PD-L1 status, with Immunohistochemical (IHC) assay confirmed by a reference laboratory, must be known prior to randomization.
Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
CA125 less than or equal to 3 x upper limit of normal (ULN) confirmed within 2 weeks of randomization using a centralized laboratory assay
Laboratory results within the 2 weeks prior to Randomization must be as follows:
Received anti-viral treatment with activity against influenza (for example amantadine, rimantadine, oseltamivir, laninamivir, peramivir, zanamivir, and ribavirin) or probenecid medication within 2 weeks prior to randomization
Subjects must have either PB or BM blasts ?5% at time of randomization.
Has been treated with an Somatostatin analogs (SSA) at any time prior to randomization, except if that treatment was for less than 15 days (e.g. peri-operatively) of short acting SSA or one dose of long acting SSA and the treatment was received more than 6 weeks prior to randomization
Has been treated with Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization
Obtained =< 28 days prior to randomization:\r\nHemoglobin > 9.0 g/dL
Ongoing or previous anti-cancer treatment within 4 weeks before randomization.
A history of events such as myocardial infarction, cerebrovascular accident or acute hepatitis within 3 months of randomization or treatment of a major active infection within one month of randomization, or any other significant event that in the opinion of the Investigator would preclude protocol therapy.
Patient who received bortezomib within 6 months of randomization to this study
Time between primary surgery and randomization > 3 months.
Receipt of any investigational medication within 4 weeks prior to randomization
Colonoscopy(or CT colonogram(within 16 months prior to randomization)
Pregnancy or lactation at the time of randomization or intention to become pregnant during the study; (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 72 hours prior to randomization)
Subjects who, in the opinion of the Investigator, have a high probability of death within 3 months of randomization due to a disease process other than the CRBSI/CLABSI
Enrollment and randomization within 12 weeks of initial cholecystectomy
Skin rash > Grade 1 from prior anti-EGFR therapy at the time of randomization.
Subjects must have at least one positive DTH skin response (more than 5 mm) to test item challenge prior to randomization.
Any antineoplastic therapy for this cancer before randomization
Excisional biopsy or lumpectomy performed prior to randomization
Treatment with immunotherapy against PCa within the previous 6 months prior to randomization
Patient may already have initiated adjuvant endocrine therapy (ET) at the time of randomization, but randomization must take place within 52 weeks of date of initial histological diagnosis of breast cancer and within 12 weeks of initiating ET
Have received radiation therapy within 4 weeks (?4 weeks) prior to randomization or has not recovered from toxic effects of the treatment that was given >4 weeks prior to randomization.
Oral, implantable or injectable contraceptives for 3 consecutive months before the baseline/randomization visit.
Total abstinence from sexual intercourse (? 1 complete menstrual cycle before the baseline/randomization visit).
Less than 16 weeks interval since the date of final surgery or less than 10 weeks from completing radiotherapy (whichever occurs last) at date of randomization.
10 weeks or more have passed since completion of radiotherapy at day of randomization and 16 weeks interval since the date of final surgery have passed.
No clinical deterioration at the time of registration/randomization
Subjects enrolled in the current study must start treatment with the single hormone agent either within 15 days prior to randomization or after randomization (before or simultaneously to the first injection of Ra-223/placebo).
Prior treatment (chemotherapy [chemo], radiation, hormone, and immune therapies) must be completed > 4 weeks prior to randomization (> 6 weeks prior to randomization for nitrosoureas, mitomycin C, and checkpoint inhibitors)
Patients must not have a history of thrombo-embolic events within 3 years prior to study randomization
Other allowed prior treatment for mHSPC: a) Maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to randomization; b) Less than or equal to (<=) 6 months of ADT prior to randomization
Completely removed melanoma by surgery performed within 12 weeks of randomization
Prior liver resection must have taken >2 months prior to randomization
Adverse effects due to prior therapy unresolved at randomization
Participant has any of the following conditions: Non-secretory or oligo-secretory multiple myeloma, active plasma cell leukemia i.e., either 20% of peripheral white blood cells or greater than 2.0 X 10^9/liter (L) circulating plasma cells by standard differential, waldenstrom's macroglobulinemia, amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), known Human Immunodeficiency Viral (HIV) infection, active hepatitis B or C infection based on blood screen tests, significant cardiovascular disease, including uncontrolled angina, severe or uncontrolled arrhythmia, recent myocardial infarction within 6 months of randomization, or congestive heart failure New York Heart Association (NYHA) Class greater than or equal to 3, Major surgery within 4 weeks prior to randomization, acute infections requiring parenteral therapy (antibiotic, antifungal, or antiviral) within 14 days prior to randomization, peripheral neuropathy greater than or equal to Grade 3 or greater than or equal to Grade 2 with pain within 2 weeks prior to randomization, uncontrolled diabetes or uncontrolled hypertension within 14 days prior to randomization, any other medical condition that, in the opinion of the Investigator, would adversely affect the participant's participation in the study
Severe infection within 4 weeks prior to randomization
Subjects with any of the following MEDICATIONS within 4 weeks prior to randomization:
Completion of all necessary baseline laboratory and radiologic investigations prior to randomization
Abnormal laboratory tests immediately prior to randomization
Participant has a history of chronic diarrheal disease within 6 months prior to randomization
Participant has participated in clinical trials of experimental agents within 4 weeks prior to randomization
Inclusion Criteria:\n\n          -  Age >= 18 years\n\n          -  Indicated and planned to receive primary radiation therapy for prostate cancer\n\n          -  Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following\n             at diagnosis: 1) Gleason score >=8 and >=cT2c, 2) Gleason score >=7, PSA >=20 nanogram\n             per milliliters (ng/mL), and >=cT2c\n\n          -  Charlson index (CCI) <=3\n\n          -  An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1\n\n          -  Adequate organ function: (1) aspartate aminotransferase (AST), alanine\n             aminotransferase (ALT), within normal limits (WNL), (2) serum creatinine less than (<)\n             1.5 milligram/deciliter (mg/dL) (<133 micromoles/Liter [mcmol/L]), (3) platelets\n             greater than or equal to (>=)140,000/microLiter (mcL), independent of transfusion\n             and/or growth factors within 3 months prior to randomization, (4) Hemoglobin >= 12.0\n             gram/deciliter (g/dL) (7.4 millimloes [mmol], independent of transfusion and/or growth\n             factors within 3 months prior to randomization\n\n          -  Participants who are sexually active (even men with vasectomies) and willing to use a\n             condom and agree not to donate sperm during the trial\n\n          -  Signed, written, informed consent\n\n          -  Be able to swallow whole study drug tablets\n\n        Exclusion Criteria: -\n\n          -  Presence of distant metastasis, (clinical stage M1). Isolated pelvic nodal disease\n             below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of\n             distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal\n             disease (clinical N stage; N1 versus N0) will be assessed by central radiological\n             review. Patients are considered eligible only if the central radiological review\n             confirms clinical stage M0.\n\n          -  Prior treatment with gonadotropin releasing hormone (GnRH) analogue or anti-androgen\n             or both for >3 months prior to randomization\n\n          -  Bilateral orchiectomy\n\n          -  History of pelvic radiation\n\n          -  Prior systemic (example [e.g.], chemotherapy) or local (e.g. radical prostatectomy,\n             cryotherapy) treatment for prostate cancer\n\n          -  History of seizure or any condition that may predispose to seizure (including, but not\n             limited to prior stroke, transient ischemic attack or loss of consciousness <= 1 year\n             prior to randomization; brain arteriovenous malformation; or intracranial masses such\n             as schwannomas and meningiomas that are causing edema or mass effect)\n\n          -  Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone,\n             ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational\n             agents (including cyproterone acetate) for prostate cancer\n\n          -  Prior treatment with radiopharmaceutical agents (e.g., strontium-89) or immunotherapy\n             (e.g., sipuleucel-T) for prostate cancer\n\n          -  Prior treatment with systemic glucocorticoids ?4 weeks prior to randomization or is\n             expected to require long-term use of corticosteroids during the study\n\n          -  Use of 5-alpha reductase inhibitors (e.g., dutasteride, finasteride) <=4 weeks prior\n             to randomization\n\n          -  Use of any investigational agent <=4 weeks prior to randomization\n\n          -  Current chronic use of opioid analgesics for >=3 weeks for oral or >7 days for\n             non-oral formulations\n\n          -  Major surgery <=4 weeks prior to randomization\n\n          -  Current or prior treatment with anti-epileptic medications for the treatment of\n             seizures\n\n          -  Gastrointestinal conditions affecting absorption\n\n          -  Known or suspected contraindications or hypersensitivity to apalutamide, bicalutamide\n             or GnRH agonists or any of the components of the formulations\n\n          -  Any condition for which, in the opinion of the investigator, participation would not\n             be in the best interest of the subject
Baseline MRI must be obtained ? 4 weeks after surgical resection but within 2 weeks prior to randomization.
Minor surgical procedure =< 7 days prior to randomization; exception: insertion of an indwelling catheter or percutaneous needle biopsy =< 48 hours prior to randomization
History of intra-abdominal abscess =< 6 months prior to randomization; Note: if the affected area was surgically resected, and there is no further risk to the area, patients may enroll
Current or recent (=< 90 days prior to randomization) endoluminal stent in the stomach, bowel, colon or rectum
Colonoscopy, sigmoidoscopy, or proctoscopy =< 7 days prior to randomization
Requirement of permanent or frequent (i.e., once per week) external drainages within two weeks prior to randomization
Stable prescription of analgesic regimen during the 2 weeks prior to randomization.
Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of randomization and is clinically stable with respect to the tumor at the time of randomization; note: patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
Anti-cancer therapy (including immunotherapy) =< 4 weeks prior to registration/randomization; exception: adjuvant Leukine =< 14 days prior to registration/randomization
Other investigational therapy (not included above) within 3 weeks of randomization
Patients who received ? 14 days of letrozole or anastrozole for advanced disease prior to randomization are eligible.
Prior randomization into this clinical study.
Use of 5-alpha reductase antagonist (i.e. finasteride, dutasteride) within 6 weeks prior to randomization
Use of antiandrogen (e.g. flutamide, nilutamide, bicalutamide) within 6 weeks prior to randomization
An interval of no more than 12 weeks between the date of surgery and the date of randomization
Treatment initiation with BST no longer than 6 months prior to randomization
STEPS 1 AND 2 AND RANDOMIZATION
Surgically rendered free of disease no more than 12 weeks before randomization.
Patients on Octreotide LAR at a fixed dose of 20 mg or 30 mg at 3-4 weeks intervals for at least 12 weeks prior to randomization in the study.
Treatment with >30 mg Octreotide LAR at 3-4 weeks intervals within 12 weeks prior to randomization in the study.
Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization in the study.
Any surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation within 12 weeks prior to randomization in the study.
UGI endoscopy/LGI endoscopy (proctoscopy/colonoscopy) performed within 30 days of randomization.
Date of randomization must be within 32 weeks of initiation of optimal systemic therapy
Patients must have adequate organ function to undergo local therapy 4 weeks +/ - 2 weeks prior to randomization per investigator discretion and institutional guidelines
Prior biological therapy for metastatic or recurrent disease within 3 weeks prior to randomization
Must have completed last cycle of second-line induction no less than 8 weeks (56 days) and no greater than 20 weeks (140 days) prior to randomization.
Last dose of prior chemotherapy received less than 4 weeks prior to randomization
Patients with nasal NK lymphoma who received local RT less than 4 weeks prior to randomization.
Insurance approval for SBRT should be obtained prior to randomization
Uncontrolled infection within 4 weeks prior to randomization
Treatment with therapeutic doses of an anticoagulant other than that used for pretreatment of the current (index) VTE episode prior to randomization;
Documentation of lesion response during the course of therapy received prior to randomization (i.e., improvement or no worsening of tumor burden; the absence of new lesions)
Screening endoscopic ultrasound if done prior to consent but within 6 weeks of expected randomization date it may be used
Other baseline laboratory evaluations must be done within 14 days prior to randomization.
By tumor biopsy if conducted within 4 weeks of randomization.
Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid or unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to randomization.
Any prior systemic therapy (before randomization) for the treatment of NSCLC (including chemoradiation), except if for non-metastatic disease and was completed at least 6 months prior to randomization
Has received antibiotic therapy for Gram-negative pneumonia for greater than 48 hours at the time of randomization
Anticancer treatment within 4 weeks of randomization, with the following exceptions:
Asymptomatic with no corticosteroid requirements for >= 4 weeks prior to randomization, AND
Chemo-, immune-, or hormone-therapy within 5 elimination half life times or 4 weeks prior to randomization, whichever is the shorter. Radiotherapy (including pre- or post-operative brachytherapy) within 4 weeks prior to randomization.
Use of LHRH agonist or antagonist treatment within 6 months prior to randomization.
Subjects treated with oral, aerosolized or intravenous (IV) ribavirin for the treatment of PIV. A forty-eight hour (48 hr) wash out period prior to randomization is allowed.
In accordance with CCTG policy, protocol treatment is to begin within 3 weeks of patient randomization
Randomization within 4 weeks of progression of disease
Malignancy other than NSCLC within 5 years prior to randomization and evidence of any other disease that contraindicates the use of an investigational or SOC drug
Presence of brain metastases, unless the patient has received adequate treatment at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to randomization;
Radiologic eligibility (measurable disease) must be must be confirmed by the BICR prior to randomization.
Has received investigational therapy within 2 weeks prior to randomization
Chemotherapy or investigational agent within 3 weeks prior to randomization or antibody therapy within 6 weeks prior to randomization
Patients moribund or with other organ failure at possible randomization:
Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization
Antiviral treatment for influenza in 2 weeks prior to randomization
Subjects treated with systemic Corticosteroid (CST) within 1 week before randomization and subjects treated with infliximab within 7 weeks before randomization
Patient may already have initiated adjuvant endocrine therapy (ET) at the time of randomization, but randomization must take place within 52 weeks of date of initial histological diagnosis of breast cancer and within 12 weeks of initiating ET
Laboratory results within 5 days prior to anticipated initiation of the first post randomization PLT transfusion:
Treatment with an anticoagulant for more than 7 days for the current blood clot, prior to randomization
Use of a Factor Xa inhibitor (e.g. apixaban, rivaroxaban, or edoxaban) =< 3 months prior to randomization
Any of the following conditions:\r\n* Intracranial bleeding =< 6 months prior to randomization\r\n* Intraocular bleeding =< 6 months prior to randomization\r\n* Gastrointestinal bleeding and/or endoscopically proven ulcer =< 6 months prior to randomization\r\n* Head trauma or major trauma =<1 month prior to randomization\r\n* Neurosurgery =< 2 weeks prior to randomization\r\n* Major surgery =< 1 week prior to randomization\r\n* Overt major bleeding at the time of randomization\r\n* Gross hematuria at the time of randomization
Previous participation in randomization in this trial
Severe infection within 4 weeks prior to randomization
Patients must not have had a screening mammogram within the last 11 months prior to date of randomization
Patient must not have undergone breast ultrasound within 12 months prior to randomization
Treatment or removal of HSIL less than 6 months prior to randomization
Any of the following conditions:\r\n* Intracranial bleeding =< 6 months prior to randomization\r\n* Intraocular bleeding =< 6 months prior to randomization\r\n* Gastrointestinal bleeding and/or endoscopically proven ulcer =< 6 months prior to randomization\r\n* Head trauma or major trauma =< 1 month prior to randomization\r\n* Neurosurgery =< 2 weeks prior to randomization\r\n* Major surgery =< 1 week prior to randomization\r\n* Gross hematuria at the time of randomization
At randomization, their planned course of antibacterial drug treatment for CDI is longer than 21 days
Colonoscopy =< 45 days prior to randomization with removal of all adenomas or polyps >= 2 mm in size
Inability to abstain from, NSAID (including aspirin), and selective COX-2 inhibitor therapy at the time of randomization through the completion of the study (the study period is defined as baseline to exit endoscopy at 18 months after randomization which defines the completion of the study); participants may take Tylenol and non-NSAID pain relievers
Any use of oral corticosteroids =< 12 weeks prior to registration/randomization
Treatment with brivudine, sorivudine, or its chemically-related analogs ? 28 days prior to the date of Randomization
anticipated to be severely immobilized for at least 24 hours after randomization
Severe infections within 4 weeks before randomization or therapeutic oral or IV antibiotics within 2 weeks before randomization