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Cervical Adenocarcinoma | 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

Cervical Adenocarcinoma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Patient has a new, unrated histologic diagnosis of 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 ; the presence or absence of para‐aortic lymph node metastasis will be based on pre-therapy 18F‐FDG PET/CT; if the baseline 18F‐FDG PET/CT identifies hypermetabolic para‐aortic disease, such patients will NOT be eligible; the patient must be able to tolerate imaging requirements of an 18F‐FDG PET/CT scan - 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 - Absolute neutrophil count > 1,500/uL - Platelets > 100,000/uL - Hemoglobin > 10 g/dL - Total bilirubin < 2.0 mg/dL - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal - Prothrombin time (PT)/activated partial thromboplastin time (aPTT) < 1.5 X institutional upper limit of normal - Creatinine =< 1.5 mg/dL to receive weekly cisplatin - Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if the estimated creatinine clearance (CCr) is >= 30 ml/min; for the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used - Patient does not have uncontrolled diabetes mellitus (i.e., fasting blood glucose > 200 mg/dL) - Patient has a life expectancy of greater than 20 weeks - Patient does not have known brain metastases (testing optional) - Patient does not have known human immunodeficiency virus syndrome (HIV, testing optional); known HIV-positive patients receiving combination antiretroviral therapy are ineligible - 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 (G6PD testing optional) - Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation of protocol therapy) Exclusion Criteria: - Patient has another concurrent active invasive malignancy - Patient has had a prior invasive malignancy diagnosed within the last three years (except [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix); patients are excluded if they have received prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician - Patient has uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within six months of protocol initiation, cardiac arrhythmia within six months of protocol initiation; known inadequately controlled hypertension; clinically significant pulmonary disease including dyspnea at rest, or patients requiring supplemental oxygen, or poor pulmonary reserve; proteinuria or clinically significant renal function impairment (baseline serum creatinine > 2 mg/dL); or psychiatric illness/social situations that would limit compliance with study requirements - Patient is receiving another investigational agent for the treatment of cancer - Patient is currently pregnant - Patient does not agree to use two forms of birth control if they are of child-bearing potential - Patients who have had a hysterectomy or are planning to have an adjuvant hysterectomy following radiation as part of their cervical cancer treatment are ineligible - Patients scheduled to be treated with adjuvant consolidation chemotherapy at the conclusion of their standard chemoradiation - Patients with self-reported or known diagnosis of G6PD deficiency

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cervical Adenocarcinoma

Cervical Adenosquamous Carcinoma

Cervical Squamous Cell Carcinoma, Not Otherwise Specified

Stage IB2 Cervical Cancer AJCC v6 and v7

Stage II Cervical Cancer AJCC v7

Stage II Vaginal Cancer AJCC v6 and v7

Stage IIA Cervical Cancer AJCC v7

Stage IIB Cervical Cancer AJCC v6 and v7

Stage III Vaginal Cancer AJCC v6 and v7

Stage IIIB Cervical Cancer AJCC v6 and v7

Stage IVA Cervical Cancer AJCC v6 and v7

Stage IVA Vaginal Cancer AJCC v6 and v7

Vaginal Adenocarcinoma

Vaginal Adenosquamous Carcinoma

Vaginal Squamous Cell Carcinoma, Not Otherwise Specified

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:CisplatinGiven IV

Radiation:External Beam Radiation TherapyUndergo EBRT

Radiation:Intensity-Modulated Radiation TherapyUndergo IMRT

Radiation:Internal Radiation TherapyUndergo brachytherapy

Other:Laboratory Biomarker AnalysisCorrelative studies

Radiation:Radiation TherapyUndergo conventional RT

Drug:TriapineGiven IV

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Arm I (cisplatin, IMRT or RT, brachytherapy)Patients receive cisplatin 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 EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.

Arm II (cisplatin, IMRT or RT, brachytherapy, triapine)Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours 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.

Study Status

Recruiting

Start Date: January 15, 2016

Completed Date: July 23, 2023

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Progression-free survival (PFS)

Secondary Outcome: Overall survival (OS)

Study sponsors, principal investigator, and references

Principal Investigator: Charles A Leath

Lead Sponsor: National Cancer Institute (NCI)

Collaborator: NRG Oncology

More information:https://clinicaltrials.gov/show/NCT02466971

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