{"classes":[{"categories":[{"measurements":[{"comment":"Median not reach due to too few patients experiencing progression","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Median not reach due to too few patients experiencing progression","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"Median number of months that patients survive without disease progression from end of treatment. Per RECIST v1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).","dispersionType":"95% Confidence Interval","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 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.\n\nBiospecimen Collection: Undergo collection of blood samples\n\nBrachytherapy: Undergo LDR brachytherapy\n\nCisplatin: Given IV\n\nComputed Tomography: Undergo FDG-PET/CT\n\nExternal Beam Radiation Therapy: Undergo pelvic EBRT\n\nFludeoxyglucose F-18: Undergo FDG-PET/CT\n\nHigh-Dose Rate Brachytherapy: Undergo HDR brachytherapy\n\nIntensity-Modulated Radiation Therapy: Undergo IMRT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nPharmacological Study: Correlative studies\n\nPositron Emission Tomography: Undergo FDG-PET/CT\n\nTriapine: Given IV and PO","id":"OG000","title":"Triapine (100mg) + 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 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.","id":"OG001","title":"Triapine (150mg) + Chemoradiation)"}],"paramType":"MEDIAN","populationDescription":"Treated patients evaluable for clinical response.","reportingStatus":"POSTED","timeFrame":"Up to 4 years and 2 months from start of treatment","title":"Progression Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}