Clinical Trials

Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg

Location:

Trial status:

Inactive

Why is this study being done?

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.

Who is eligible to participate?

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

Last updated: 12/13/2011

NCT ID:

NCT00589121