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A Randomized Phase II 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

Status
Active
Cancer Type
Cervical Cancer
Gynecologic Cancers
Trial Phase
Phase II
Eligibility
18 and over, Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT02466971
Protocol IDs
NRG-GY006 (primary)
NCI-2015-00835
Study Sponsor
National Cancer Institute

Summary

TRIAL STATUS: Active

This randomized phase II 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.

Objectives

PRIMARY OBJECTIVES:

I. 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 cancer.

SECONDARY OBJECTIVES:

I. To determine the post-therapy 3-month fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) metabolic complete rate of response by European Organization for Research and Treatment of Cancer (EORTC) and National Cancer Institute (NCI) guidelines in women with uterine cervix cancer.

TERTIARY OBJECTIVES:

I. To determine the acute (< 30-day) treatment-related toxicity as assessed by Common Toxicity Criteria for Adverse Events (CTCAE), version 4.

II. To determine the chronic or late (>= 30-day) treatment-related toxicity as assessed by CTCAE, version 4.

III. To determine overall survival after triapine-cisplatin radio-chemotherapy and cisplatin radio-chemotherapy.

IV. To determine peripheral blood methemoglobin proportion before and after triapine infusion (optional for Arm 2 patients).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cisplatin intravenously (IV) over 90 minutes on days 2, 9, 16, 23, 30 (and day 36 or 37 at the treating physician's discretion). Patients then undergo external beam radiation therapy (EBRT) (either conventional radiation therapy [RT] or intensity modulated radiation therapy [IMRT]) once daily (QD) 5 days a week for 25 fractions followed by low dose rate (LDR) or high dose rate (HDR) brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 90 minutes on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 2 years, and then every 6 months for 3 years.

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