Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer

Status unconfirmed · Phase 2

Conditions studied: Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation, Endometrial Mucinous Adenocarcinoma, Endometrial Squamous Cell Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma, Recurrent Endometrial Endometrioid Adenocarcinoma, Recurrent Endometrial Serous Adenocarcinoma, Recurrent Endometrial Undifferentiated Carcinoma, Recurrent Uterine Corpus Cancer

In brief

This randomized phase II trial studies radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with endometrial cancer that has come back. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. 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. It is not yet known whether giving radiation therapy together with cisplatin is more effective than radiation therapy alone in treating patients with endometrial cancer.

Key facts

Study ID: NCT00492778
Run by: GOG Foundation
People needed: 165
Starts: 2008-02-25
Last updated by the study team: 2023-03-29

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

All patients must have undergone complete hysterectomy and bilateral salpingo-oophorectomy at the time of original therapy for their uterine carcinoma
Patients must have a biopsy with histologically confirmed diagnosis of recurrent endometrial cancer confined to the pelvis and/or vagina and no evidence of extrapelvic disease
Patients must have endometrial carcinoma including endometrioid adenocarcinoma, adenocarcinoma with squamous differentiation, mucinous adenocarcinoma, squamous cell carcinoma, mixed carcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, and serous adenocarcinoma histologies
Patients must have no evidence of extrapelvic disease; complete workup staging should be performed prior to initiation of therapy to rule-out presence of metastatic disease; this should include: computed tomography (CT) scan of the thorax with IV contrast, as well as a CT of the pelvis and abdomen with IV and oral (PO) contrast performed using multi-detector CT and equal or less than 5 mm slice thickness; if the patient is unable to tolerate contrast, then magnetic resonance imaging (MRI) with IV gadolinium should be performed; a chest x-ray should be done first, and if abnormal, then a CT scan of the chest should be done
Primary surgical debulking before protocol therapy is permissible; this would include removal of gross symptomatic disease in the pelvis and/or vagina
Exenterative surgery is not permissible; patients with complete resection of gross recurrent disease are eligible
Patients may have received prior hormone therapy and/or systemic chemotherapy; such therapy must have been completed at least 6 months prior to study entry and the patient has clear evidence of disease subsequent to such therapy; patients must not have received neoadjuvant chemotherapy for the present recurrent disease
Patients must have Gynecologic Oncology Group (GOG) performance status 0, 1, or 2
Patients must have an estimated survival greater or equal to 3 months
Absolute neutrophil count (ANC) >= 1,500/mm\^3 , equivalent to Common Toxicity Criteria (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 3.0) grade 1
Platelets >= 100,000/mm\^3 (CTCAE v 3.0 grade 0-1)
Creatinine =< institutional upper limit normal (ULN), CTCAE v 3.0 grade 0; NOTE: if creatinine > ULN, creatinine clearance must be > 50 mL/min
Bilirubin =< 1.5 x ULN (CTCAE v 3.0 grade 1)
Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x ULN (CTCAE v 3.0 grade 0-1)
Alkaline phosphatase =< 2.5 x ULN (CTCAE v 3.0 grade 0-1)
Neuropathy (sensory and motor) =< CTCAE v 3.0 grade 1
Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
Patients who have met the pre-entry requirements
Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

You may not qualify if…

Patients with evidence of disease outside of the pelvis, including presence of positive periaortic or inguino-femoral nodes
Patients who have received previous vaginal, pelvic, or abdominal irradiation
Patients who received chemotherapy directed at the present recurrence
Patients with septicemia or severe infection
Patients who have circumstances that will not permit completion of this study or the required follow-up
Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields
Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
Patients who have undergone complete surgical resection of the recurrent tumor and have no evidence of residual disease evaluable clinically and by CT or MRI imaging, following resection
Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias within 6 months of registration
Patients with history of active collagen vascular disease
Patients with GOG performance grade of 3 or 4

Where it is running

Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States
Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
Mills-Peninsula Medical Center — Burlingame, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States
Eden Hospital Medical Center — Castro Valley, California, United States
Sutter Davis Hospital — Davis, California, United States
UC San Diego Moores Cancer Center — La Jolla, California, United States
Loma Linda University Medical Center — Loma Linda, California, United States
Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
Memorial Medical Center — Modesto, California, United States
Palo Alto Medical Foundation-Camino Division — Mountain View, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology — Mountain View, California, United States
Sutter Cancer Research Consortium — Novato, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
Palo Alto Medical Foundation Health Care — Palo Alto, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville, California, United States
Sutter Roseville Medical Center — Roseville, California, United States
Sutter Medical Center Sacramento — Sacramento, California, United States
University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
University of California San Diego — San Diego, California, United States
California Pacific Medical Center-Pacific Campus — San Francisco, California, United States
Palo Alto Medical Foundation-Santa Cruz — Santa Cruz, California, United States
Sutter Pacific Medical Foundation — Santa Rosa, California, United States
Sutter Auburn Faith Hospital — Auburn, California, United States

Full record on ClinicalTrials.gov

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