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NRG-GY006

Trial

Clinical Trial Title

Radiation Therapy and Cisplatin With or Without Triapine in Treating Patients With Newly Diagnosed Stage IB2, II, or IIIB-IVA Cervical Cancer or Stage II-IVA Vaginal Cancer

Trial Status

Closed to Enrollment

Start Date

July 8, 2016

Trial Type

Cancer - Adult Oncology

Specific Condition

Cervical Cancer

Description

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.

Eligibility Criteria

  • Stage IB2 (> 5 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix
  • Or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone
  • GOG performance status of 0, 1, or 2 or equivalent
  • Life expectancy of greater than 20 weeks
  • Age is ≥ 18 years
  • Does not have known brain metastases
  • Does not have known human immunodeficiency virus syndrome

Ineligibility Criteria

  • Has another concurrent active invasive malignancy
  • Prior invasive malignancy diagnosed within the last three years (except [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix)
  • Is receiving another investigational agent for the treatment of cancer

Treatment

Group 1 will get the usual cisplatin chemotherapy and radiation therapy used for this type of cancer

Group 2 will get the usual cisplatin chemotherapy and radiation therapy used for this type of cancer plus an investigational study drug called triapine three times per week

IRB Number

Legacy IRB

Principal Investigator Name

Colleen C. McCormick, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

ocologyresearch@lhs.org

Last Updated: Wednesday, January 27, 2021 12:56:52 PM