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Radiation Therapy Sandwiched Between Paclitaxel and Carboplatin in Patients With High-risk Endometrial Cancer

2014-08-27 03:16:58 | BioPortfolio

Summary

In this study, radiation is "sandwiched" between paclitaxel/carboplatin chemotherapy in attempts to decrease the chance of the cancer returning in the pelvis or elsewhere in the body. This study will evaluate the tolerability of combining radiation with chemotherapy in this way. We will also evaluate any side effects that patients may experience with this treatment.

Description

- Before chemotherapy, patients will receive extra fluid by IV for 2 hours, and will be given medicine to prevent side effects from the chemotherapy drugs.

- Chemotherapy treatments will be given intravenously in the outpatient clinic. Patients will receive IV paclitaxel/carboplatin chemotherapy every 21 days for 3 cycles.

- After 3 cycles of chemotherapy, patients will receive external beam radiotherapy. Radiation will be delivered to the patient's pelvis at the dose prescribed by the Radiation Oncologist.

- External radiation will be given once a day, five days a week (Monday-Friday) for 5 weeks.

- Patients will then receive internal high-dose radiation, which will be given once a week for three weeks. This type of radiation is given through a vaginal cylinder, a device that is inserted in the vagina that directs the radiation to your tumor. It is a procedure that is done with anesthesia.

- The 4th cycle of chemotherapy will overlap with the high dose radiation.

- The remainder of the planned 6 cycles of paclitaxel/carboplatin therapy will continue to be administered every 21 days.

- Prior to and during the study, tests and procedures will be performed; including physical examinations, routine blood tests, urine tests, ECG, medical history and vital signs, radiologic examinations.

- The study treatment will proceed as long as the tumor does not grow and the patient isn't experiencing any severe side effects.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Endometrial Cancer

Intervention

Paclitaxel, Carboplatin, Pelvic and Para-Aortic Radiation 6MV Photon Beam Energy, High Dose Radiation

Location

Montefiore Medical Center
Bronx
New York
United States
10461

Status

Recruiting

Source

Montefiore Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:58-0400

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