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A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination With Intravenous Triapine in Women With Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

Primary Objective To evaluate the efficacy of the experimental regimen of triapine (3AP), cisplatin, and radiation to increase progression-free survival relative to the standard / control regimen of cisplatin and radiation in women with uterine cervix and vaginal cancer. Secondary Objectives To determine the post-therapy 3-month 18F-FDG PET/CT metabolic complete response rate in the uterine cervix and vaginal by treatment arm. To determine overall survival after triapine-cisplatin radio-chemotherapy and cisplatin radio-chemotherapy. To evaluate incidence and severity of hematologic and gastrointestinal (GI) adverse events by radiation modality; image guided intensity modulated radiation therapy (IG-IMRT) versus conventional pelvic radiotherapy. (05/30/2017) To summarize and compare differences in acute adverse events (CTCAE, v4.0) by treatment arm and radiation modality. (05/30/2017) To summarize and compare differences in chronic or late (≥ 30-days from off study treatment date) adverse events (CTCAE, v4.0) by treatment arm and by radiation modality. (05/30/2017) Tertiary Objectives To determine peripheral blood methemoglobin proportion before and after triapine infusion (optional for Arm 2 patients). To explore whether knowledge-based planning (KBP) can improve IG-IMRT plans compared to plans that would have been delivered without KBP, estimate the resulting toxicity reduction using NTCP models, and determine whether KBP should be a requirement for future IG-IMRT protocols. To evaluate incidence and severity of hematologic and gastrointestinal (GI) adverse events by radiation modality; image guided intensity modulated radiation therapy (IG-IMRT) versus conventional pelvic radiotherapy. (05/30/2017) To summarize and compare differences in acute adverse events (CTCAE v4.0) by treatment arm and by radiation modality. (05/30/2017) To summarize and compare differences in chronic or late (greater than or equal to 30-days from off study treatment date) adverse events (CTCAE, v4.0) by treatment arm and by radiation modality. (05/30/2017) To determine the post-therapy 3-month 18F-FDG PET/CT metabolic complete response rate by treatment arm. To compare acute toxicity and chemotherapy delivery for atlas-based IG-IMRT vs. PET/CT-based IG-IMRT vs. conventional RT, and assess the impact of treatment on changes in hematopoietic compensatory response. To determine the post-therapy 3-month 18F-FDG PET/CT metabolic complete response rate by treatment arm. To compare acute toxicity and chemotherapy delivery for atlas-based IG-IMRT vs. PET/CT-based IG-IMRT vs. conventional RT, and assess the impact of treatment on changes in hematopoietic compensatory response.

Primary Objective To evaluate the efficacy of the experimental regimen of triapine (3AP), cisplatin, and radiation to increase progression-free survival relative to the standard / control regimen of cisplatin and radiation in women with uterine cervix and vaginal cancer. Secondary Objectives To determine the post-therapy 3-month 18F-FDG PET/CT metabolic complete response rate in the uterine cervix and vaginal by treatment arm. To determine overall survival after triapine-cisplatin radio-chemotherapy and cisplatin radio-chemotherapy. To evaluate incidence and severity of hematologic and gastrointestinal (GI) adverse events by radiation modality; image guided intensity modulated radiation therapy (IG-IMRT) versus conventional pelvic radiotherapy. (05/30/2017) To summarize and compare differences in acute adverse events (CTCAE, v4.0) by treatment arm and radiation modality. (05/30/2017) To summarize and compare differences in chronic or late (≥ 30-days from off study treatment date) adverse events (CTCAE, v4.0) by treatment arm and by radiation modality. (05/30/2017) Tertiary Objectives To determine peripheral blood methemoglobin proportion before and after triapine infusion (optional for Arm 2 patients). To explore whether knowledge-based planning (KBP) can improve IG-IMRT plans compared to plans that would have been delivered without KBP, estimate the resulting toxicity reduction using NTCP models, and determine whether KBP should be a requirement for future IG-IMRT protocols. To evaluate incidence and severity of hematologic and gastrointestinal (GI) adverse events by radiation modality; image guided intensity modulated radiation therapy (IG-IMRT) versus conventional pelvic radiotherapy. (05/30/2017) To summarize and compare differences in acute adverse events (CTCAE v4.0) by treatment arm and by radiation modality. (05/30/2017) To summarize and compare differences in chronic or late (greater than or equal to 30-days from off study treatment date) adverse events (CTCAE, v4.0) by treatment arm and by radiation modality. (05/30/2017) To determine the post-therapy 3-month 18F-FDG PET/CT metabolic complete response rate by treatment arm. To compare acute toxicity and chemotherapy delivery for atlas-based IG-IMRT vs. PET/CT-based IG-IMRT vs. conventional RT, and assess the impact of treatment on changes in hematopoietic compensatory response. To determine the post-therapy 3-month 18F-FDG PET/CT metabolic complete response rate by treatment arm. To compare acute toxicity and chemotherapy delivery for atlas-based IG-IMRT vs. PET/CT-based IG-IMRT vs. conventional RT, and assess the impact of treatment on changes in hematopoietic compensatory response.