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Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery

NCT00448643 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-12-15

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may also make tumor cells more sensitive to cisplatin. Giving radiation therapy together with cisplatin after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase I trial is studying the side effects and best dose of whole-abdominal radiation therapy when given together with cisplatin in treating patients with stage III or stage IV endometrial cancer that has been removed by surgery.

Conditions

Interventions

RADIATION

Vaginal Brachytherapy

High-Dose Rate \[HDR\] or Low-Dose Rate \[LDR\], no earlier than during last cycle of Carboplatin/Taxol chemotherapy; or no later than 1 week before cisplation and WAR therapy

DRUG

Cisplatin

Weekly at 40 mg/m2 (maximum of 70 mg) for 6 weeks, start no later than 6 weeks from last cycle of standard of care carboplatin and taxol chemotherapy

RADIATION

Whole Abdominal Radiation [WAR] Therapy

Whole Abdominal Radiation Therapy, Dose Escalated \[2-Levels\]; 6 -8 hours after administration of Cisplatin chemotherapy

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Aaron H. Wolfson, MD · University of Miami Sylvester Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00448643 on ClinicalTrials.gov