OB/GYN & Women's Health
PHASE3
● Phase III
Triapine Added to Cisplatin and Radiation for Cervical/Vaginal Cancer: Phase III Results
ClinicalTrials.gov
Published March 28, 2026
National Cancer Institute (NCI)
NCT02466971 ↗
This randomized phase III trial investigates the addition of triapine to the standard regimen of cisplatin and radiation therapy in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. The study, sponsored by the National Cancer Institute, enrolled 450 participants and aimed to assess whether the experimental combination improves overall survival compared to the standard treatment. The primary objective is to evaluate the efficacy of triapine, cisplatin, and radiation in increasing overall survival. Secondary objectives include determining the impact on progression-free survival. Tertiary objectives focus on the incidence and severity of hematologic and gastrointestinal adverse events, comparing image-guided intensity modulated radiation therapy (IG-IMRT) with conventional pelvic radiotherapy. The study began on May 10, 2016, with primary completion on January 26, 2023, and results posted on January 5, 2024. The trial is not recruiting new participants.
AI Accuracy Review: 9/10
· Auto-published
For women facing advanced cervical and vaginal cancers, the search for better treatments is crucial. This study investigates whether adding a new anti-cancer drug called triapine to the standard treatment of cisplatin and radiation can improve overall survival. The trial involves 450 women with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. The researchers aim to find out if this combination therapy can help women live longer compared to the usual treatment alone. In addition to survival, the study will also look at how well patients do without their cancer getting worse and will assess any side effects from the different types of radiation used. The hope is that triapine could offer a new option for women battling these challenging cancers, making a real difference in their lives.
What this means for you: Adding triapine to standard treatment may improve survival for women with advanced cervical and vaginal cancers.
View Original Abstract ↓
Status: ACTIVE_NOT_RECRUITING | Phase: PHASE3
Condition(s): Advanced Vaginal Adenocarcinoma, Advanced Vaginal Adenosquamous Carcinoma, Advanced Vaginal Squamous Cell Carcinoma, Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma
Intervention(s): Brachytherapy (RADIATION), Cisplatin (DRUG), External Beam Radiation Therapy (RADIATION), Intensity-Modulated Radiation Therapy (RADIATION), Laboratory Biomarker Analysis (OTHER)
This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.
Detailed: PRIMARY OBJECTIVE:
I. To evaluate the efficacy of the experimental regimen of triapine (3AP), cisplatin, and radiation to increase overall survival relative to the standard/control regimen of cisplatin and radiation in women with uterine cervix or vaginal cancer.
SECONDARY OBJECTIVE:
I. To determine the relative progression-free survival impact of triapine-cisplatin radio-chemotherapy and cisplatin radio-chemotherapy.
TERTIARY OBJECTIVES:
I. 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) II. To summarize and compare differences in acute adverse events (Common Terminology Criteria for Adverse Events \[CTCAE
Primary Outcome(s): Overall Survival (OS) Rate at 3 Years
Enrollment: 450 (ACTUAL)
Lead Sponsor: National Cancer Institute (NCI)
Start: 2016-05-10 | Primary Completion: 2023-01-26
Results posted: 2024-01-05
