NCT02595879 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 100mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO
- id
- FG000
- title
- 100 mg PO Triapine + Chemoradiation
- description
- Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 100mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO
- id
- FG001
- title
- 150 mg PO Triapine + Chemoradiation
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 0
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Cohort 1 / Dose Level 1
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 4
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 4
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Cohort 2 / Dose Level 2
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 0
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Cohort 3 / Dose Level 1
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Did not complete treatment regimen
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 11
- group Id
- FG001
- num Subjects
- 0
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 10
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Expansion Cohort
Complete source fields
- groups
- description
- Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 100mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO
- id
- FG000
- title
- 100 mg PO Triapine + Chemoradiation
- description
- Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and 100mg PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO
- id
- FG001
- title
- 150 mg PO Triapine + Chemoradiation
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 0
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Cohort 1 / Dose Level 1
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 4
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 4
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Cohort 2 / Dose Level 2
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 0
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Cohort 3 / Dose Level 1
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Did not complete treatment regimen
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 11
- group Id
- FG001
- num Subjects
- 0
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 10
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Expansion Cohort
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