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.

  • 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