ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg

This study is currently recruiting participants.
Study NCT00589121.   Last updated on October 3, 2008.   Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by

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.

Detailed 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 CTCAE v3.0 criteria.
  • 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 ≥ grade 2, 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: 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.

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 ]
Condition  Lymphedema
Musculoskeletal Complications
Radiation Fibrosis
Radiation Toxicity
Sarcoma
Intervention  Procedure: 3-dimensional conformal radiation therapy
Procedure: chemotherapy
Procedure: intensity-modulated radiation therapy
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  102
Start Date  March 2008
Completion Date
Eligibility Criteria 

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 (group 1)
  • Platelet count ≥ 100,000/mm^3 (group 1)
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed) (group 1)
  • Bilirubin ≤ 1.5 mg/dL (group 1)
  • AST or ALT ≤ 2 times upper limit of normal (group 1)
  • Serum creatinine ≤ 1.6 mg/dL OR creatinine clearance ≥ 55 mL/min (group 1)
  • LVEF ≥ 50% by MUGA or echocardiogram (group 1)
  • 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 (group 1), defined as 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 or fungal infection requiring intravenous antibiotics
    • Known AIDS

      • HIV testing is not required for study entry
    • Grade 3-4 electrolyte abnormalities (according to CTCAE v3.0 criteria), 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 < 3 mmol/L OR > 6 mmol/L
      • Sodium < 130 mmol/L OR > 155 mmol/L

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
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 
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    
Information Provided By National Cancer Institute (NCI)
Verification Date October 2008
First Received Date  January 5, 2008
Last Updated Date October 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers