Radiation Therapy Sandwiched Between Paclitaxel and Carboplatin in Patients With High-risk Endometrial Cancer
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.
Radiation: Pelvic and Para-Aortic Radiation 6MV Photon Beam Energy
Radiation: High Dose Radiation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Phase II Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With High-Risk Endometrial Cancer After Standard Surgical Staging|
- To assess and document location of disease recurrence (distant vs. local. vs. both) using this treatment regimen. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To evaluate the toxicity of pelvic radiation "sandwiched" between cycles of paclitaxel/carboplatin chemotherapy in patients with high-risk endometrial cancer. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- To evaluate the associations of cancer recurrence with tumor tissue expression levels. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
- 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.
|Contact: Loraine Centrilla, RNfirstname.lastname@example.org|
|United States, New York|
|Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Loraine Centrilla, RN 718-405-8082 email@example.com|
|Principal Investigator: Dennis Yi-Shin Kuo, MD|
|Sub-Investigator: Mark H. Einstein, MD, MS|
|Sub-Investigator: Gary L. Golberg, MD|
|Sub-Investigator: Gloria Shining Huang, MD|
|Sub-Investigator: Harriet Smith, MD|
|Sub-Investigator: David Smotkin, MD|
|Sub-Investigator: Nicole Nevadunsky, MD|
|Sub-Investigator: Subhakar Mutyala, MD|
|Sub-Investigator: Madhur Garg, MD|
|Principal Investigator:||Dennis Yi-Shin Kuo, MD||Montefiore Medical Center|