IRB #

STUDY00023833

Title

[NCI CIRB] NRG-GY006: 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, or stage II, IIIB, or IVA cancer of the uterine cervix or stage II-IVA vaginal cancer

Principal Investigator

Jenna Kahn

Study Purpose

This study is being done to see if the addition of triapine to the standard therapy for cervical or vaginal cancer more effective than standard chemotherapy and radiation. Also, to confirm the effectiveness of the combination of triapine with the usual cisplatin and radiation therapy. Finally, to find out if this approach is better or worse than the usual approach for cervical or vaginal cancer.

Medical Condition(s)

uterine cancer
cervical cancer
vaginal cancer
radiation therapy
cisplatin
triapine

Eligibility Criteria

Patient has a new, unrated histologic diagnosis of stage IB2 (> 4 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix (FIGO 2009) or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone; the presence or absence of para-aortic lymph node metastasis will be based on pre-therapy 18F-FDG PET/CT;

Patient must provide study specific informed consent prior to study entry

Patient must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 or equivalent

Patient does not have uncontrolled diabetes mellitus (i.e., fasting blood glucose > 200 mg/dL)

Patient does not have known brain metastases

Patient does not have known human immunodeficiency virus syndrome

Patient does not have a known allergy to compounds of similar or biologic composition as triapine

Patient does not have known glucose-6-phosphate dehydrogenase (G6PD) deficiency as the condition interferes with triapine antidote metabolism

Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation of protocol therapy)

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

5 years

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials, trials@ohsu.edu, 503-494-1080

Sponsor

National Cancer Institute (NCI)

Recruitment End

01/31/2024

Compensation Provided

No


Go Back