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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.
Verified by National Cancer Institute (NCI), June 2008

Sponsors and Collaborators: Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00589121
  Purpose

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.


Condition Intervention Phase
Lymphedema
Musculoskeletal Complications
Radiation Fibrosis
Radiation Toxicity
Sarcoma
Procedure: 3-dimensional conformal radiation therapy
Procedure: chemotherapy
Procedure: intensity-modulated radiation therapy
Phase II

Genetics Home Reference related topics:   lymphedema-distichiasis syndrome   

MedlinePlus related topics:   Cancer    Lymphedema    Soft Tissue Sarcoma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment:   102
Study Start Date:   March 2008
Estimated Primary Completion Date:   January 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Group 1: 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.
Procedure: 3-dimensional conformal radiation therapy
Performed preoperatively once daily, 5 days a week, for 4½-5 weeks
Procedure: chemotherapy
Up to 6 courses of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy
Procedure: intensity-modulated radiation therapy
Performed preoperatively once daily, 5 days a week, for 4½-5 weeks
Group 2: Experimental
Patients undergo 3D-CRT or IMRT once daily, 5 days a week, for 5 weeks.
Procedure: 3-dimensional conformal radiation therapy
Performed preoperatively once daily, 5 days a week, for 4½-5 weeks
Procedure: intensity-modulated radiation therapy
Performed preoperatively once daily, 5 days a week, for 4½-5 weeks

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589121

Locations
United States, North Carolina
Duke Comprehensive Cancer Center     Recruiting
      Durham, North Carolina, United States, 27710
      Contact: Clinical Trials Office - Duke Comprehensive Cancer Center     888-275-3853        
United States, Wisconsin
Medical College of Wisconsin Cancer Center     Recruiting
      Milwaukee, Wisconsin, United States, 53226
      Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C     414-805-4380        

Sponsors and Collaborators
Radiation Therapy Oncology Group
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    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000582196, RTOG-0630
First Received:   January 5, 2008
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00589121
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
radiation fibrosis  
radiation toxicity  
lymphedema  
musculoskeletal complications  
stage I adult soft tissue sarcoma
stage II adult soft tissue sarcoma
adult extraskeletal chondrosarcoma
stage III adult soft tissue sarcoma

Study placed in the following topic categories:
Lung Diseases, Interstitial
Fibrosis
Malignant mesenchymal tumor
Wounds and Injuries
Disorders of Environmental Origin
Soft tissue sarcomas
Lymphedema
Neoplasms, Connective and Soft Tissue
Lymphatic Diseases
Respiratory Tract Diseases
Lung Diseases
Chondrosarcoma
Sarcoma
Radiation Pneumonitis
Pneumonia
Radiation Injuries

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes

ClinicalTrials.gov processed this record on July 25, 2008




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