Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg

PHASE2CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

December 31, 2012

Study Completion Date

May 21, 2018

Conditions
LymphedemaMusculoskeletal ComplicationsRadiation FibrosisRadiation ToxicitySarcoma
Interventions
DRUG

Chemotherapy

Up to 6 courses of investigator's choice of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy

RADIATION

Radiation therapy

Preoperative IGRT (3D-CRT or IMRT): If receiving neoadjuvant or adjuvant chemotherapy or no chemotherapy: 50 Gy (2 Gy once a day, 5 times a week). If receiving concurrent or interdigitated chemotherapy: 44 Gy (2 Gy once a day, 5 times a week). Postoperative radiotherapy boost for patients with positive margins following surgery: 16 Gy (2 Gy once a day, 5 times a week) external beam radiation therapy or 16 Gy at ≤ 80 cGy per hour brachytherapy or 3.4 Gy/fraction in 4 fractions brachytherapy or 10-12.5 Gy in a single fraction intraoperative radiation therapy boost.

PROCEDURE

Surgery

Resection of the sarcoma with the goal of having negative pathologic margins. Every effort should be made to have limb preservation surgery unless there is documented evidence of tumor progression that would require amputation for an appropriate negative margin resection. All lesions of the extremities should be treated with wide excision.

Trial Locations (17)

19713

CCOP - Christiana Care Health Services, Newark

32224

Mayo Clinic - Jacksonville, Jacksonville

33136

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami

40207

Norton Suburban Hospital, Louisville

48073

William Beaumont Hospital - Royal Oak Campus, Royal Oak

53226

Medical College of Wisconsin Cancer Center, Milwaukee

55905

Mayo Clinic Cancer Center, Rochester

32610-0232

University of Florida Shands Cancer Center, Gainesville

33612-9497

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa

02114

Massachusetts General Hospital, Boston

03756-0002

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon

14263-0001

Roswell Park Cancer Institute, Buffalo

17033-0850

Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center, Hershey

05819

Norris Cotton Cancer Center - North, Saint Johnsbury

T6G 1Z2

Cross Cancer Institute at University of Alberta, Edmonton

N6A 4L6

London Regional Cancer Program at London Health Sciences Centre, London

H2W 1S6

McGill Cancer Centre at McGill University, Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK