Doxorubicin Plus External-Beam Radiation Therapy in Treating Patients With Soft Tissue Sarcoma

NCT00004109 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-08-02

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of doxorubicin plus external-beam radiation therapy in treating patients who have soft tissue sarcoma.

Conditions

  • Sarcoma

Interventions

DRUG

Doxorubicin Hydrochloride

Doxorubicin dose will not exceed 20 mg/m2 per week IV over 4 days every week for 5 weeks

RADIATION

Radiation Therapy (RT)

External-beam radiotherapy at a dose of 50 Gy (2.0 x 25 fractions, weeks 1-5).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Peter W. Pisters, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-03-31
Primary Completion
2001-09-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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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 NCT00004109 on ClinicalTrials.gov