Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles

Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted

Vaginal Cuff Brachytherapy

Carboplatin IV on day 1 of a 21 day cycle for 3 cycles

Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles

Kathleen Moore, MD

The purpose of this study is to determine the feasibility of treatment in patients with high risk endometrial cancer treated by vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy.

Before the patient begins the study:

Endometrial cancer is commonly treated with surgery. The patient must have already had surgery including hysterectomy (removal of the uterus) prior to being considered eligible for this study. The surgery may also include removal of pelvic and para-aortic lymph nodes. Following the surgery, the doctor will identify if the patient has factors related to the cancer which places the patient at a greater risk for the cancer returning.

Prior to participating in this study there are exams, tests or procedures to find out if the patient can be treated in the study. Most are part of regular cancer care.

Treatment:

All patients will receive radiation therapy followed by three cycles of dose dense paclitaxel and carboplatin chemotherapy. Radiation therapy will be delivered either by LDR or HDR brachytherapy and must be specified at the time of enrollment. The vaginal brachytherapy should be started within 12 weeks of surgery (within 2 weeks of enrollment). Chemotherapy should start within 3 weeks of initiating brachytherapy.

Study participation will be up to two years.

Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer

Phase II Trial of Vaginal Cuff Brachytherapy Followed by Adjuvant Chemotherapy With Carboplatin and Dose Dense Paclitaxel in Patients With High-Risk Endometrial Cancer

Defined as completion of vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy

Frequency and severity of adverse events as assessed by the CTCAE v4

Proportion of participants who experienced failure in regional or distant sites

time from study entry to the first tumor recurrence

The contributing cause of death for patients with high risk endometrial cancer

University of Oklahoma

Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles

Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted

Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles

Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles

Spots Global Cancer Trial Database for clear cell endometrial cancer