Status:
UNKNOWN
Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Endometrial Clear Cell Adenocarcinoma
Endometrial Serous Adenocarcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This randomized phase III trial studies carboplatin and paclitaxel to see how well they work with or without cisplatin and radiation therapy in treating patients with stage I-IVA endometrial cancer. D...
Detailed Description
PRIMARY OBJECTIVES: I. To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence or ...
Eligibility Criteria
Inclusion
- All patients with surgical stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria including clear cell and serous papillary and undifferentiated carcinoma
- Surgical stage III disease includes those patients with positive adnexa, parametrial involvement, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement
- Surgical stage IVA patients with bladder or bowel mucosal involvement, but no spread outside the pelvis
- Patients with FIGO 2009 surgical stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology
- Surgery must have included a hysterectomy and bilateral salpingo-oophorectomy; pelvic lymph node sampling and para-aortic lymph node sampling are optional
- Patients with a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
- White blood cell (WBC) \>= 3,000/mcl
- Absolute neutrophil count (ANC) \>= 1,500/mcl
- Platelet count \>= 100,000/mcl
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =\< 2.5 x upper limit of normal (ULN)
- Alkaline phosphatase =\< 2.5 times ULN
- Bilirubin =\< 1.5 times ULN
- Creatinine =\< institutional ULN
- Patients who have met the pre-entry requirements; testing values/results must meet eligibility criteria
- Patients who have signed an approved informed consent and authorization permitting release of personal health information
- Entry into the study is limited to no more than 8 weeks from the date of surgery
Exclusion
- Patients with carcinosarcoma
- Patients with recurrent endometrial cancer
- Patients with residual tumor after surgery (any single site) exceeding 2 cm in maximum dimension
- Patients who have had pelvic or abdominal radiation therapy
- Patients with positive pelvic washings as the only extra-uterine disease are NOT eligible if the histology is other than clear cell or papillary serous carcinoma
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy
- Patients with an estimated survival of less than three months
- Patients with FIGO 2009 stage IVB endometrial cancer
- Patients with parenchymal liver metastases
- Patients who have received prior chemotherapy for endometrial cancer
- Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment
Key Trial Info
Start Date :
June 29 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2024
Estimated Enrollment :
813 Patients enrolled
Trial Details
Trial ID
NCT00942357
Start Date
June 29 2009
End Date
July 28 2024
Last Update
October 19 2021
Active Locations (670)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
Tennessee Valley Gynecologic Oncology
Huntsville, Alabama, United States, 35805
3
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36688
4
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States, 99508