PP-Gemcitabine & External Beam Radiation-Sarcomas

NCT02046304 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2016-04-06

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest safe dose of gemcitabine that can be given with radiotherapy before surgery to treat sarcoma. This study will also look at how well this treatment controls sarcoma.

Conditions

  • Sarcoma

Interventions

DRUG

Gemcitabine

Starting dose: 400 mg/m2 by vein on days 1, 8, 22, 29, 43, and 50.

RADIATION

Radiation Therapy

Radiation therapy dose of 50 Gy in 25 fractions at 2.0 Gy per fraction. Radiotherapy given once daily (Monday through Friday) for 5 weeks.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

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 NCT02046304 on ClinicalTrials.gov