Clinical trial · Interventional
Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg
A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
| Musculoskeletal Complications | — | UNRESOLVED | — |
| Radiation Fibrosis | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Radiation therapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A - Chemotherapy
- description
- Radiation therapy with neoadjuvant or adjuvant or concurrent or interdigitated chemotherapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
- interventionNames
- Drug: Chemotherapy
- Radiation: Radiation therapy
- Procedure: Surgery
- type
- EXPERIMENTAL
- label
- Cohort B - No Chemotherapy
- description
- Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
- interventionNames
- Radiation: Radiation therapy
- Procedure: Surgery
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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\*
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2 times upper limit of normal\*
* Serum creatinine ≤ 1.6 mg/dL OR creatinine clearance ≥ 55 mL/min\*
* Left ventricular ejection fraction (LVEF) ≥ 50% by multiple gated acquisition scan (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 agentsReferences
Publications (2)
- DERIVEDWang D, Harris J, Kraybill WG, Eisenberg B, Kirsch DG, Ettinger DS, Kane JM 3rd, Barry PN, Naghavi A, Freeman CR, Chen YL, Hitchcock YJ, Bedi M, Salerno KE, Severin D, Godette KD, Larrier NA, Curran WJ Jr, Torres-Saavedra PA, Lucas DR. Pathologic Complete Response and Clinical Outcomes in Patients With Localized Soft Tissue Sarcoma Treated With Neoadjuvant Chemoradiotherapy or Radiotherapy: The NRG/RTOG 9514 and 0630 Nonrandomized Clinical Trials. JAMA Oncol. 2023 May 1;9(5):646-655. doi: 10.1001/jamaoncol.2023.0042. PMID 36995690
- DERIVEDWang D, Zhang Q, Eisenberg BL, Kane JM, Li XA, Lucas D, Petersen IA, DeLaney TF, Freeman CR, Finkelstein SE, Hitchcock YJ, Bedi M, Singh AK, Dundas G, Kirsch DG. Significant Reduction of Late Toxicities in Patients With Extremity Sarcoma Treated With Image-Guided Radiation Therapy to a Reduced Target Volume: Results of Radiation Therapy Oncology Group RTOG-0630 Trial. J Clin Oncol. 2015 Jul 10;33(20):2231-8. doi: 10.1200/JCO.2014.58.5828. Epub 2015 Feb 9. PMID 25667281