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

• Status: Active, not recruiting
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GOG Foundation; Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Succinylcholine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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