Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg
This study is ongoing, but not recruiting participants.
Sponsor:
Radiation Therapy Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00589121
First received: January 5, 2008
Last updated: December 13, 2011
Last verified: September 2010
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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 |
Drug: chemotherapy Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- 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:
- 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 [ Designated as safety issue: Yes ]
- Other grade 3-5 adverse events as measured by CTCAE v3.0 [ Designated as safety issue: Yes ]
- Pattern of first failure [ 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 ]
- 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: | 83 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: chemotherapy
Up to 6 courses of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy
Radiation: 3-dimensional conformal radiation therapy
Performed preoperatively once daily, 5 days a week, for 4½-5 weeks
Radiation: intensity-modulated radiation therapy
Performed preoperatively once daily, 5 days a week, for 4½-5 weeks
|
|
Experimental: Group 2
Patients undergo 3D-CRT or IMRT once daily, 5 days a week, for 5 weeks.
|
Radiation: 3-dimensional conformal radiation therapy
Performed preoperatively once daily, 5 days a week, for 4½-5 weeks
Radiation: 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.
- 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.
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
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
- Bilirubin ≤ 1.5 mg/dL*
- AST or ALT ≤ 2 times upper limit of normal*
- Serum creatinine ≤ 1.6 mg/dL OR creatinine clearance ≥ 55 mL/min*
- LVEF ≥ 50% by 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589121
Locations
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, Florida | |
| University of Florida Shands Cancer Center | |
| Gainesville, Florida, United States, 32610-0232 | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | |
| Miami, Florida, United States, 33136 | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Kentucky | |
| Norton Suburban Hospital | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| William Beaumont Hospital - Royal Oak Campus | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| United States, Pennsylvania | |
| Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| United States, Vermont | |
| Norris Cotton Cancer Center - North | |
| Saint Johnsbury, Vermont, United States, 05819 | |
| United States, Wisconsin | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, Alberta | |
| Cross Cancer Institute at University of Alberta | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Ontario | |
| London Regional Cancer Program at London Health Sciences Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Canada, Quebec | |
| McGill Cancer Centre at McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
Sponsors and Collaborators
Radiation Therapy Oncology Group
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 Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00589121 History of Changes |
| Other Study ID Numbers: | CDR0000582196, RTOG-0630 |
| Study First Received: | January 5, 2008 |
| Last Updated: | December 13, 2011 |
| Health Authority: | United States: Federal Government |
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 |
Additional relevant MeSH terms:
|
Fibrosis Lymphedema Radiation Injuries Sarcoma Radiation Pneumonitis Pathologic Processes Lymphatic Diseases Wounds and Injuries |
Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Lung Injury |
ClinicalTrials.gov processed this record on June 13, 2013