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Preoperative Thalidomide With Radiation Therapy For Patients With Low-Grade Primary Soft Tissue Sarcoma or Thalidomide With Radiation Therapy and Chemotherapy For Patients With High-Grade or Intermediate-Grade Primary Soft Tissue Sarcoma of the Arm, Leg, or Body Wall

NCT00089544 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-04-13

Study results available
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Summary

Thalidomide may stop the growth of soft tissue sarcoma by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and dacarbazine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving thalidomide together with radiation therapy and/or chemotherapy before surgery may shrink the tumor so that it can be removed. This phase II trial is studying how well giving preoperative (before surgery) thalidomide together with radiation therapy works in treating patients with low-grade primary soft tissue sarcoma, and how well giving thalidomide together with radiation therapy, doxorubicin, ifosfamide, and dacarbazine works in treating patients with high-grade or intermediate-grade primary soft tissue sarcoma of the arm, leg, chest wall, or abdominal wall.

Conditions

  • Recurrent Adult Soft Tissue Sarcoma
  • Stage I Adult Soft Tissue Sarcoma AJCC v7
  • Stage II Adult Soft Tissue Sarcoma AJCC v7
  • Stage III Adult Soft Tissue Sarcoma AJCC v7

Interventions

DRUG

Dacarbazine

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

BIOLOGICAL

Filgrastim

Given subcutaneously

DRUG

Ifosfamide

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

RADIATION

Radiation Therapy

Undergo radiotherapy

DRUG

Thalidomide

Given orally

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgical resection

Sponsors & Collaborators

  • Radiation Therapy Oncology Group

    collaborator NETWORK

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Burton Eisenberg · Radiation Therapy Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-17
Primary Completion
2011-09-27
Completion
2013-11-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00089544 on ClinicalTrials.gov