{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"30","upperLimit":"86","value":"62"},{"groupId":"OG001","lowerLimit":"32","upperLimit":"100","value":"100"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"The mCR rate at recommended phase 2 dose, defined as a metabolic complete response on PET/CT will be defined as greater than -66% reduction in tumor FDG uptake at sites of abnormal tumor FDG uptake noted on pre-treatment FDG-PET study (considering normal cardiac or liver blood pool).","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":"NUMBER","populationDescription":"Patients who received at least 3 weeks of therapy (cisplatin + triapine), and had their disease re-evaluated with a 3-month post treatment 18F-FDG-PET/CT","reportingStatus":"POSTED","timeFrame":"At 3 months post-treatment","title":"Fludeoxyglucose F18-Positron Emission Tomography Computed Tomography Metabolic Complete Response (mCR) Rate","type":"SECONDARY","unitOfMeasure":"percentage response-evaluable patients"}