Spots Global Cancer Trial Database for PP-Gemcitabine & External Beam Radiation-Sarcomas

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: PP-Gemcitabine & External Beam Radiation-Sarcomas

Official Title: A Phase I Study of Preoperative Concomitant Gemcitabine and External-Beam Radiation Therapy and Surgical Resection for Patients With Extremity and Trunk Soft Tissue Sarcomas

Study ID: NCT02046304

Conditions

Sarcoma

Interventions

Gemcitabine

Radiation Therapy

Study Description

Brief 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.

Detailed Description: Before the start of treatment, participants will have a physical exam, blood tests, a MRI scan, and a chest x-ray. A PET scan may be done if thought necessary. Participants will receive the drug gemcitabine by vein along with radiation therapy on Days 1, 8, 22, 29, 43, and 50. Radiation treatments will be given 5 days a week for 5 weeks. The gemcitabine and radiotherapy will be given on an outpatient basis. Chemotherapy and/or radiotherapy may be stopped if side effects become severe. About 4 to 6 weeks after the final dose of gemcitabine, surgery will be done to remove the tumor or to remove any previous surgical scar and leftover tumor. During the combined treatment, participants will be seen weekly by the doctor in charge of radiotherapy or by the study nurse. Blood tests will be done every week during treatment. A MRI scan and a chest x-ray will be done within 14 days before surgery. A PET scan will be done if thought necessary. After the surgery is done, participants will return to M. D. Anderson for follow-up visits every 4 months for the first 2 years, every 6 months for 3 years, and then yearly from then on. An ultrasound and MRI scan (of the extremity or trunk) will be done 3 months after completion of all treatment. Ultrasound scans will be performed at each visit. A MRI scan will only be done again at later visits if needed. This is an investigational study. Gemcitabine is approved for use by the FDA. Its use together with radiation therapy in this study is experimental. About 36 individuals will take part in the study. All will be enrolled at M. D. Anderson.