Women with childbearing potential (WOCBP) who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method; a woman of childbearing potential is defined of one who is biologically capable of becoming pregnant; reliable contraception should be used from trial screening and must be continued throughout the study If the patient is a woman is of childbearing potential, a serum pregnancy test, obtained within days prior to step registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception If the patient is a woman of child bearing potential (WOCBP), she has had a negative serum or urine pregnancy test within week prior to treatment. Pregnant or lactating woman (any woman of childbearing potential who has menstruated within the year prior to enrolment will undergo pregnancy testing within hours prior to receiving the first dose of study medication) Not a woman of childbearing potential (WOCBP) as defined in protocol OR Any woman of childbearing potential, unless she: Agrees to take appropriate precautions to avoid becoming pregnant (with at least % certainty) during the study and has a negative serum pregnancy test within days prior to starting treatment. A woman of childbearing potential (WCBP), defined as a woman who is < years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within days prior to initiating study treatment A woman of childbearing potential (WCBP), defined as a woman who is < years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within days prior to study registration; Note: If study treatment is not initiated within days after the pregnancy test, the pregnancy test must be repeated Negative urine pregnancy test within week prior to Cycle Day for each woman of childbearing potential Negative urine pregnancy test within week prior to Cycle Day for each woman of childbearing potential If a woman is of childbearing potential, a negative serum pregnancy test must be documented A woman of childbearing potential (WCBP), defined as a woman who is < years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within days prior to initiating study treatment A woman of childbearing potential must have a negative serum or urine pregnancy test at screening within days and again within hours prior to dosing A woman of childbearing potential (WCBP), defined as a woman who is < years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within days prior to initiating study treatment If the patient is a woman of child bearing potential (WOCBP), she has had a negative serum or urine pregnancy test within week prior to treatment. If the patient is a woman of child bearing potential (WOCBP), she has had a negative serum or urine pregnancy test within week prior to treatment. Women with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method; reliable contraception should be used from trial screening and must be continued throughout the study; a woman of childbearing potential is defined as one who is biologically capable of becoming pregnant If a woman of child bearing potential (WOCBP), she has had a negative serum or urine pregnancy test within weeks prior to treatment. A woman of childbearing potential must have a negative serum pregnancy test at screening within days prior to randomization Negative pregnancy test (if woman of childbearing potential) A woman of childbearing potential must have a negative serum or urine pregnancy test within days before commencing treatment. Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use methods of reliable birth control simultaneously Women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within hours prior to enrollment \Woman of childbearing potential\ is defined as any woman who has not undergone a hysterectomy and who has had menses at any time in the preceding consecutive months The patient is a woman of child bearing potential (WOCBP) who has had a negative serum or urine pregnancy test within week prior to SL- treatment (intervals shorter than week are acceptable if required by institutional guidelines). If a woman of childbearing potential, a negative serum pregnancy test prior to randomization. A woman of childbearing potential must have a negative serum or urine pregnancy test at screening within days prior to randomization Woman Women of childbearing potential must have a negative pregnancy test (urine or blood) pre-operatively as per the standard hospital policy; a woman of childbearing potential is defined as one who is biologically capable of becoming pregnant ALL PARTICIPANTS: A negative serum or urine pregnancy test for woman of childbearing potential Woman of childbearing potential, a negative serum or urine pregnancy test Woman of childbearing potential, a negative serum or urine pregnancy test