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Proton Chemoradiotherapy for High-Risk Soft Tissue Sarcomas

NCT00881595 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-02-10

No results posted yet for this study

Summary

The goal of this study is to evaluate the effects of temozolomide and radiation combination in the treatment intended of soft tissue sarcomas.

This study will also look at the tumor tissue that was removed during your initial biopsy and your final surgery for information that may help to treat soft tissue sarcoma in the future. In addition the investigators will examine a sample of your normal tissue (optional) from the inside of your mouth/cheek (to compare it to your tumor tissue) before starting treatment.

Conditions

  • Soft Tissue Sarcomas

Interventions

DRUG

Chemoradiotherapy Temozolomide

Temozolomide: 75 mg/m2 five days per week during radiotherapy for 5 weeks.Temozolomide: 75 mg/m2 five days per week during radiotherapy for 5 weeks. Temozolomide should be taken orally 1 hour before each session of radiotherapy during weekdays (Monday through Friday). The dose will be determined using the body surface area (BSA) calculated at the beginning of the concurrent treatment. The BSA will be calculated from the height obtained at the pretreatment visit and the weight obtained before the first day of treatment. The concurrent treatment will last until the end of radiotherapy.

RADIATION

Proton therapy

50 cobalt gray equivalent(CGE), 25 daily fractions, 5 weeks (2 CGE/fx)

PROCEDURE

Proton Chemoradiotherapy followed by surgery

Proton Chemoradiotherapy followed by surgery. Resection of tumor at 4-6 weeks post-treatment.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Daniel J Indelicato, MD · University of Florida Proton Therapy Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-11-30
Completion
2012-11-30

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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 NCT00881595 on ClinicalTrials.gov