Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer

Description

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

September 2008

Estimated Completion Date

January 2017

Interventions

  • 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

Specialties

  • Obstetrics & Gynecology: Gynecologic Oncology
  • Family Medicine: Women`s Health
  • Oncology: Gynecologic Oncology
  • Physician Assistant: Obstetrics/Gynecology,Women`s Health

MeSH Terms

  • Endometrial Neoplasms

Study ID

Montefiore Medical Center -- MMC-08-03-060

Status

Unknown

Trial ID

NCT01041027

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

25

Sponsor

Montefiore Medical Center

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
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 Kuo 718-405-8082 dykuo@montefiore.org

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