Radiation Therapy, Paclitaxel, and Carboplatin in Treating 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.
Study Start Date
Estimated Completion Date
- Radiation: High Dose Radiation
- Radiation: Pelvic and Para-Aortic Radiation 6MV Photon Beam Energy
- Radiation: Internal Radiation Therapy
- Other: Laboratory Biomarker Analysis
- Drug: Carboplatin
- Radiation: External Beam Radiation Therapy
- Drug: Paclitaxel
- Obstetrics & Gynecology: Gynecologic Oncology
- Family Medicine: Women`s Health
- Oncology: Gynecologic Oncology
- Physician Assistant: Obstetrics/Gynecology,Women`s Health
- Endometrial Neoplasms
Montefiore Medical Center -- MMC-08-03-060
Montefiore Medical Center
- Histologically-documented high-risk endometrioid adenocarcinoma with no visible residual disease, defined by the following criteria: 1. Surgical stage I disease with < 50 myometrial invasion and grade 3 tumor (IBG3) with lymphovascular space involvement 2. Surgical stage I disease with > 50% myometrial invasion and grade 2 or 3 tumor (ICG2, ICG3) 3. Any surgical stage II disease (IIA, IIB) 4. Any surgical stage III disease (IIIA, IIIB, IIIC) and 5. Any surgical stage IV disease with no residual macroscopic tumor
- Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings as per standard GOG criteria.
- Age > 18 years.
- ECOG performance status of < 2.
- Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values: 1. Serum SGOT and /or SGPT > 2.5 times the institutional upper limit of normal 2. Total serum bilirubin > 1.5 mg/dl 3. History of chronic or active hepatitis 4. Serum creatinine > 2.0 mg/dl 5. Platelets < 100,000/mm3 6. Absolute neutrophil count (ANC) < 1500/mm3 7. Hemoglobin < 8.0 g/dl (the patient may be transfused prior to study entry).
- Patient has severe or uncontrolled concurrent medical disease (eg Un-controlled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
- Patient with any prior chemotherapy or radiotherapy for pelvic malignancy.
- Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry.
- Patients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five years.
18 Years and older
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Study Locations and Contact Information (2)
|Albert Einstein College of Medicine - Bronx, New York||40.3 miles||None||None||None|
|Albert Einstein College of Medicine - Bronx, New York||40.3 miles||Dennis Y Kuoemail@example.com|