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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00589121 |
Purpose
RATIONALE: Image-guided radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a lower dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying the side effects and how well image-guided radiation therapy works in treating patients with primary soft tissue sarcoma of the shoulder, arm, hip, or leg.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphedema Musculoskeletal Complications Radiation Fibrosis Radiation Toxicity Sarcoma |
Drug: chemotherapy Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity |
| Estimated Enrollment: | 102 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 1: Experimental
Patients undergo 3-D conformal radiotherapy (3D-CRT) or intensity-modulated therapy (IMRT) once daily, 5 days a week, for 4½-5 weeks. Patients also receive up to 6 courses of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy.
|
Drug: chemotherapy
Up to 6 courses of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy
Radiation: 3-dimensional conformal radiation therapy
Performed preoperatively once daily, 5 days a week, for 4½-5 weeks
Radiation: intensity-modulated radiation therapy
Performed preoperatively once daily, 5 days a week, for 4½-5 weeks
|
|
Group 2: Experimental
Patients undergo 3D-CRT or IMRT once daily, 5 days a week, for 5 weeks.
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Radiation: 3-dimensional conformal radiation therapy
Performed preoperatively once daily, 5 days a week, for 4½-5 weeks
Radiation: intensity-modulated radiation therapy
Performed preoperatively once daily, 5 days a week, for 4½-5 weeks
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Neoadjuvant radiotherapy: Patients are assigned to 1 of 2 treatment groups.
After completion of study treatment, patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary soft tissue sarcoma of the upper extremity (including shoulder) or lower extremity (including hip)
No histopathological diagnosis of any of the following:
Chondrosarcoma
Tumor must be surgically resectable, as determined by a surgeon within the past 8 weeks
No lymph node or distant metastases, according to the following within the past 8 weeks:
MRI with contrast of the primary tumor
CT scan of the chest
PATIENT CHARACTERISTICS:
No severe, active co-morbidity (group 1), defined as any of the following:
Known AIDS
Grade 3-4 electrolyte abnormalities (according to CTCAE v3.0 criteria), including any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Show 20 Study Locations| Study Chair: | Dian Wang, MD, PhD | Medical College of Wisconsin |
| Investigator: | Scott Okuno, MD | Mayo Clinic |
| Investigator: | Burton L. Eisenberg, MD | Norris Cotton Cancer Center |
| Investigator: | John M. Kane, MD | Roswell Park Cancer Institute |
| Investigator: | David G. Kirsch, MD, PhD | Duke University |
More Information
| Responsible Party: | Radiation Therapy Oncology Group ( Walter John Curran, Jr ) |
| Study ID Numbers: | CDR0000582196, RTOG-0630 |
| Study First Received: | January 5, 2008 |
| Last Updated: | October 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00589121 History of Changes |
| Health Authority: | Unspecified |
|
radiation fibrosis radiation toxicity lymphedema musculoskeletal complications |
stage I adult soft tissue sarcoma stage II adult soft tissue sarcoma adult extraskeletal chondrosarcoma stage III adult soft tissue sarcoma |
|
Lung Diseases, Interstitial Neoplasms by Histologic Type Fibrosis Wounds and Injuries Disorders of Environmental Origin Lymphedema Lymphatic Diseases Neoplasms, Connective and Soft Tissue |
Neoplasms Pathologic Processes Respiratory Tract Diseases Lung Diseases Sarcoma Radiation Pneumonitis Radiation Injuries |