Clinical Trial: Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
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.
Detailed Summary:
OBJECTIVES:
Primary
- To determine the effect of reduced radiation volume using image-guided radiotherapy (IGRT) on lymphedema ≥ grade 2, subcutaneous fibrosis, and joint stiffness at 2 years in patients with primary soft tissue sarcoma of the extremity.
Secondary
- To estimate the rates of other grade 3-5 adverse events as measured by Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0.
- To determine the pattern of first failure, including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression.
- To estimate the rates of local failure, local-regional failure, distant failure, distant disease-free survival, disease-free survival, overall survival, and second primary tumor.
- To estimate the rate of wound complications.
- To correlate the degree of late radiation morbidity (defined as any lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years with scores on the clinical measure, Musculoskeletal Tumor Rating Scale (MTRS).
OUTLINE: This is a multicenter study.
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Neoadjuvant radiotherapy: Patients are assigned to 1 of 2 treatment groups (group 1 closed to accrual as of 01/08/10).
- Group 1 (closed to accrual as of 01/08/10): Patients undergo 3-D conformal radiotherapy (3D
Sponsor: Radiation Therapy Oncology Group
Current Primary Outcome: 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 [ Time Frame: From start of treatment to 2 years ]
Late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by European Organization for Research and Treatment of Cancer (EORTC)/Radiation Therapy Oncology Group (RTOG) criteria
Original Primary Outcome: 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
Current Secondary Outcome:
- Late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis or joint stiffness) at 2 years from the start of radiotherapy as measured by CTCAE v3.0 [ Time Frame: From start of treatment to 2 years ]
- Other grade 3-5 adverse events as measured by CTCAE v3.0 [ Time Frame: From start of treatment to last follow-up ]
- Pattern of first failure [ Time Frame: From registration to date of local, regional or distant progression ]
- Time to local failure [ Time Frame: From registration to date of failure (local progression) or death or last follow-up ]
- Time to regional failure [ Time Frame: From registration to date of failure (regional progression) or death or last follow-up ]
- Time to distant failure [ Time Frame: From registration to date of failure (distant progression) or death or last follow-up ]
- Distant disease-free survival [ Time Frame: From registration to date of failure (distant progression or death) or last follow-up ]
- Disease-free survival [ Time Frame: From registration to date of failure (local, regional or distant progression or death) or last follow-up ]
- Overall survival [ Time Frame: From registration to date of death or last follow-up ]
- Time to second primary tumor [ Time Frame: From registration to date of failure (second primary tumor) or death or last follow-up ]
- Wound complications [ Time Frame: From date of surgery to 4 months post-surgery ]
- 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) [ Time Frame: From start of treatment to 2 years ]
Original Secondary Outcome:
- 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
- Other grade 3-5 adverse events as measured by CTCAE v3.0 criteria
- Pattern of first failure, including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression
- Time to local failure
- Time to regional failure
- Time to distant failure
- Distant disease-free survival
- Disease-free survival
- Overall survival
- Time to second primary tumor
- Rate of wound complications
- 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)
Information By: Radiation Therapy Oncology Group
Dates:
Date Received: January 5, 2008
Date Started: March 2008
Date Completion:
Last Updated: November 14, 2015
Last Verified: November 2015
- Group 1 (closed to accrual as of 01/08/10): Patients undergo 3-D conformal radiotherapy (3D