Overview

This trial is active, not recruiting.

Conditions lymphedema, musculoskeletal complications, radiation fibrosis, radiation toxicity, sarcoma
Treatments chemotherapy, 3-dimensional conformal radiation therapy, intensity-modulated radiation therapy
Phase phase 2
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date March 2008
End date December 2012
Trial size 98 participants
Trial identifier NCT00589121, CDR0000582196, RTOG-0630

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
chemotherapy
Up to 6 courses of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy
3-dimensional conformal radiation therapy
Performed preoperatively once daily, 5 days a week, for 4½-5 weeks
intensity-modulated radiation therapy
Performed preoperatively once daily, 5 days a week, for 4½-5 weeks
(Experimental)
Patients undergo 3D-CRT or IMRT once daily, 5 days a week, for 5 weeks.
3-dimensional conformal radiation therapy
Performed preoperatively once daily, 5 days a week, for 4½-5 weeks
intensity-modulated radiation therapy
Performed preoperatively once daily, 5 days a week, for 4½-5 weeks

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed primary soft tissue sarcoma of the upper extremity (including shoulder) or lower extremity (including hip) - Incisional or core biopsy required within the past 8 weeks - No histopathological diagnosis of any of the following: - Rhabdomyosarcoma - Extraosseous primitive neuroectodermal tumor (PNET) - Soft tissue Ewing sarcoma - Osteosarcoma - Kaposi sarcoma - Angiosarcoma - Aggressive fibromatosis (desmoid tumor) - Dermatofibrosarcoma protuberans - Chondrosarcoma - Extraskeletal myxoid chondrosarcoma allowed - Tumor must be surgically resectable, as determined by a surgeon within the past 8 weeks - Limb-preservation surgery alone would not provide adequate local control, as determined by the surgeon - No sarcoma of the hand, foot, head, neck, or intra-abdominal or retroperitoneal region or body wall - No sarcoma ≥ 32 cm in any direction - No lymph node or distant metastases, according to the following within the past 8 weeks: - History/physical examination, including a detailed description of the location, size, and stage of the sarcoma - MRI with contrast of the primary tumor - The maximum dimension of the primary tumor is measured in MRI images - CT scan of the chest - Multiple pulmonary nodules < 8 mm without a histological diagnosis detected incidentally on a non-screening CT scan may be allowed - CT scan with contrast of the abdomen and pelvis in patients with intermediate- or high-grade sarcoma of the upper thigh - No recurrent tumor after prior potentially curative therapy PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed) - Bilirubin ≤ 1.5 mg/dL* - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2 times upper limit of normal* - Serum creatinine ≤ 1.6 mg/dL OR creatinine clearance ≥ 55 mL/min* - Left ventricular ejection fraction (LVEF) ≥ 50% by multiple gated acquisition scan (MUGA) or echocardiogram* - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other invasive malignancy within the past 3 years, except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix - No severe, active co-morbidity, including any of the following*: - Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months - Transmural myocardial infarction within the past 6 months - Acute bacterial infection or fungal infection requiring intravenous antibiotics - Acquired Immune Deficiency Syndrome (AIDS) or immunocompromised patients - HIV testing not required - No NCI CTCAE v 3.0 grade 3-4 electrolyte abnormalities, including any of the following*: - Calcium < 7 mg/dL or > 12.5 mg/dL - Glucose < 40 mg/dL or > 250 mg/dL - Magnesium < 0.9 mg/dL or > 3 mg/dL - Potassium < 3mmol/L or > 6 mmol/L - Sodium < 130 mmol/L or > 155 mmol/L NOTE: *Applies to group 1 only, which was closed to accrual as of 01/08/10) PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior excisional biopsy in which the majority of the tumor (≥ 50%) is removed - No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields - No other concurrent investigational agents

Additional Information

Official title A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity
Principal investigator Dian Wang, MD, PhD
Description 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-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. - Group 2: Patients undergo 3D-CRT or IMRT once daily, 5 days a week, for 5 weeks. - Surgery: At 4-8 weeks after completion of neoadjuvant radiotherapy, patients undergo surgical resection of the tumor. Patients with positive tumor margins (residual tumor) undergo intraoperative radiotherapy boost or proceed to adjuvant radiotherapy within 2 weeks after surgery. - Adjuvant radiotherapy: Patients undergo either external-beam radiotherapy (EBRT) once daily for 8 fractions or brachytherapy. 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.