Phase 2
Completed N=98
Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg
Lymphedema · Musculoskeletal Complications · Radiation Fibrosis · Radiation Toxicity
Source: ClinicalTrials.gov NCT00589121 ↗
Enrolled (actual)
98
Serious AEs
16.9%
Results posted
Jul 2017
Primary outcomePrimary: Rate of 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 — 10.5 percentage of participants — p=0.0005
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of 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 |
10.5 | 0.0005 sig |
| SECONDARY Local Failure Rate at Two Years |
11.4 | — |
| SECONDARY Regional Failure Rate at Two Years |
— | — |
| SECONDARY Distant Failure Rate at Two Years |
37.3 | — |
| SECONDARY Distant Disease-free Survival Rate at Two Years |
61.4 | — |
| SECONDARY Disease-free Survival Rate at Two Years |
58.1 | — |
| SECONDARY Overall Survival Rate at Two Years |
80.6 | — |
| SECONDARY Second Primary Tumor Rate at Two Years |
5.1 | — |
| SECONDARY Late Radiation Morbidity Rate (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by CTCAE v3.0 |
8.8 | — |
| SECONDARY Percentage of Patients With Wound Complications |
36.6 | — |
| SECONDARY Pattern of First Failure |
1; 8; 0; 1; 1; 29 | — |
| SECONDARY Mean Musculoskeletal Tumor Rating Scale (MSTS) by Late Radiation Morbidity at Two Years |
31.3; 25.0 | — |
| SECONDARY Percentage of Patients With Other CTCAE, v.3.0 Grade 3-5 Adverse Events |
38.0 | — |
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 12.5 mg/dL
- Glucose 250 mg/dL
- Magnesium 3 mg/dL
- Potassium 6 mmol/L
- Sodium 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
Data sourced from ClinicalTrials.gov (NCT00589121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.