Trial of Cisplatin Plus Radiation Followed by Carbo and Taxol Vs. Sandwich Therapy of Carbo and Taxol Followed Radiation Then Further Carbo and Taxol

Completed · Phase 3

Conditions studied: Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage IIIA Uterine Corpus Cancer, Stage IIIB Uterine Corpus Cancer, Stage IIIC Uterine Corpus Cancer, Stage IVA Uterine Corpus Cancer

In brief

To determine if treatment with cisplatin and radiation followed by carbo and taxol reduces the rate of recurrence when compared to sandwich therapy.

Key facts

Study ID

NCT02501954

Run by

Women's Cancer Care Associates, LLC

People needed

48

Starts

2015-03-01

Expected to finish

2023-11-01

Last updated by the study team

2024-07-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• All patients with Surgical Stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria, including clear cell and serous papillary and undifferentiated carcinomas.
• 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 includes 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 salpingooophorectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional.
• Patients with a GOG Performance Status of 0, 1, or 2.
• Patients with adequate organ function, reflected by the following parameters:
• WBC ≥ 3000/mcl Absolute neutrophil count (ANC) ≥ 1500/mcl Platelet count ≥ 100,000/mcl SGOT, SGPT, and alkaline phosphatase ≤ 2.5 X upper limit of normal (ULN) Bilirubin ≤ 1.5 X ULN Creatinine ≤ institutional ULN
• Patients must be 18 years of age or older.
• Entry into the study is limited to no more than 8 weeks from the date of surgery.

You may not qualify if…

• Patients with carcinosarcoma.
• Patients with recurrent endometrial cancer.
• Patients with residual tumor after surgery (any single site) exceeding 1 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.

Where it is running

• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Munson Health Care — Traverse City, Michigan, United States
• Atlantic Health — Morristown, New Jersey, United States
• Women's Cancer Care Associates, LLC — Albany, New York, United States
• The Ohio State University — Columbus, Ohio, United States
• Gunderson Lutheran Medical Foundation — La Crosse, Wisconsin, United States
• CHUM Hopital Notre-Dame — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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