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Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus
 
Region Sponsors
California - Southern
Gynecologic Oncology Group
 
Acronym KP IRB No.
GOG-0238
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
Female: Child, Adult, Older Adult with histologically confirmed diagnosis of Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation, Endometrial Serous Adenocarcinoma, Recurrent Uterine Corpus Carcinoma
 
Purpose
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;
 
Detailed Description
PRIMARY OBJECTIVES: To assess whether pelvic radiation therapy with concurrent cisplatin is more promising with respect to progression-free survival than pelvic radiation therapy alone in the treatment of recurrent uterine carcinoma limited to the pelvis and vagina; SECONDARY OBJECTIVES: To capture the sites of recurrence subsequent to treatment with pelvic radiation with or without concurrent weekly cisplatin in women with recurrent uterine carcinoma.To estimate overall survival of patients with recurrent uterine carcinoma treated with pelvic radiation therapy with or without concurrent weekly cisplatin.To estimate the prognostic significance of the location (central pelvis versus vagina) and size of the recurrence, in addition to the prognostic significance in the salvage setting of the histological subtype, grade, patient age, race, performance status, and the presence of lymph-vascular space involvement of the original tumor at the time of initial hysterectomy. To evaluate toxicity derived from the combined cisplatin and radiation compared with radiation alone in this patient population; OUTLINE: Patients are randomized to 1 of 2 treatment arms; Please contact study team for more eligibility criteria.
 
Gender Age Limit
Female
 
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
  • Please contact study team for more eligibility criteria.
 
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

 
Keywords and/or Specific Medical Conditions
  • Adenocarcinoma
  • Neoplasms
  • Adenocarcinoma, Clear Cell
  • Neoplasms by Histologic Type
  • Carcinoma
  • Neoplasms, Cystic, Mucinous, and Serous
  • Carcinoma, Adenosquamous
  • Neoplasms, Glandular and Epithelial
  • Carcinoma, Endometrioid
  • Oncology (Pediatrics)
  • Cystadenocarcinoma
  • Uterine Neoplasms
  • Cystadenocarcinoma, Serous
  • Oncology (Adult)
  • Endometrial Neoplasms
 
KP Clinical Facility
  • West LA
 
Clinical Area
  • Oncology (Adult)
  • Oncology (Pediatrics)


Principal Investigator:
Scott Lentz, MD
Contact Information:
- Cynthia Brown
-626-564-5667
-West LA


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