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| Descriptive Information Fields | |||||||||||||||||||||
| Brief Title † | Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg | ||||||||||||||||||||
| Official Title † | A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity | ||||||||||||||||||||
| Brief Summary | 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. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study.
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. |
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| Study Phase | Phase II | ||||||||||||||||||||
| Study Type † | Interventional | ||||||||||||||||||||
| Study Design † | Treatment | ||||||||||||||||||||
| Primary Outcome Measure † | Effect of reduced radiation volume using image-guided radiotherapy (IGRT) on late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC/RTOG criteria [ Designated as safety issue: Yes ] | ||||||||||||||||||||
| Secondary Outcome Measure † | Effect of reduced radiation volume using IGRT on late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, and joint stiffness) at 2 years from the start of radiotherapy as measured by CTCAE v3.0 criteria [ Designated as safety issue: Yes ] Other grade 3-5 adverse events as measured by CTCAE v3.0 criteria [ Designated as safety issue: Yes ] Pattern of first failure, including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression [ Designated as safety issue: No ] Time to local failure [ Designated as safety issue: No ] Time to regional failure [ Designated as safety issue: No ] Time to distant failure [ Designated as safety issue: No ] Distant disease-free survival [ Designated as safety issue: No ] Disease-free survival [ Designated as safety issue: No ] Overall survival [ Designated as safety issue: No ] Time to second primary tumor [ Designated as safety issue: No ] Rate of wound complications [ Designated as safety issue: No ] Impact of late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years on the clinical measure, Musculoskeletal Tumor Rating Scale (MTRS) [ Designated as safety issue: Yes ] |
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| Condition † | Lymphedema Musculoskeletal Complications Radiation Fibrosis Radiation Toxicity Sarcoma |
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| Intervention † | Procedure: 3-dimensional conformal radiation therapy Procedure: chemotherapy Procedure: intensity-modulated radiation therapy |
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| MEDLINE PMIDs | |||||||||||||||||||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||||||||||||||||||
| Recruitment Status † | Recruiting | ||||||||||||||||||||
| Enrollment † | 102 | ||||||||||||||||||||
| Start Date † | March 2008 | ||||||||||||||||||||
| Completion Date | |||||||||||||||||||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts †† | |||||||||||||||||||||
| Location Countries † | United States, Canada | ||||||||||||||||||||
| Administrative Information Fields | |||||||||||||||||||||
| NCT ID † | NCT00589121 | ||||||||||||||||||||
| Organization ID | CDR0000582196 | ||||||||||||||||||||
| Secondary IDs †† | RTOG-0630 | ||||||||||||||||||||
| Study Sponsor † | Radiation Therapy Oncology Group | ||||||||||||||||||||
| Collaborators †† | National Cancer Institute (NCI) | ||||||||||||||||||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||||||
| Verification Date | October 2008 | ||||||||||||||||||||
| First Received Date † | January 5, 2008 | ||||||||||||||||||||
| Last Updated Date | October 3, 2008 | ||||||||||||||||||||