If the patient is a woman is of childbearing potential, a serum pregnancy test, obtained within 14 days prior to step 2 registration, must be negative, and, if randomized to receive radiation therapy, the woman must agree to use contraception
Pregnant or lactating woman (any woman of childbearing potential who has menstruated within the year prior to enrolment will undergo pregnancy testing within 72 hours prior to receiving the first dose of study medication)
A woman of childbearing potential (WCBP), defined as a woman who is < 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within 14 days prior to initiating study treatment
Women of childbearing potential must not be pregnant with a negative urine pregnancy test within 72 hours prior to registration and non-lactating; postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; woman status post oophorectomy or hysterectomy are considered non-childbearing potential
A woman of childbearing potential (WCBP), defined as a woman who is < 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within 14 days prior to study registration; Note: If study treatment is not initiated within 7 days after the pregnancy test, the pregnancy test must be repeated
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 < 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within 7 days prior to initiating study treatment
For women of childbearing potential (WCBP): negative serum ?-human chorionic gonadotropin (?hCG) pregnancy test within 1 week before first dose (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 24 consecutive months [women ?55 years] or 12 consecutive months [women >55 years])
A woman of childbearing potential (WCBP), defined as a woman who is < 60 years of age and has not had a hysterectomy, must have a documented negative serum pregnancy test within 7 days prior to initiating study treatment
A woman of childbearing potential must have a negative serum pregnancy test at screening within 14 days prior to randomization
For women of childbearing potential (WCBP): negative serum ?-human chorionic gonadotropin (?hCG) pregnancy test within 1 week before randomization (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 24 consecutive months [women ? 55 years] or 12 consecutive months [women > 55 years])
Negative pregnancy test (if woman of childbearing potential)
Women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 72 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 24 consecutive months
If a woman of childbearing potential, a negative serum pregnancy test prior to randomization.
Woman