Clinical trial · Interventional
Radiation Therapy With or Without SU5416 in Treating Patients With Soft Tissue Sarcoma
A Randomized Phase I/II Study Of Preoperative Radiotherapy With/Without SUGEN 5416 (NSC # 696819; A TK Inhibitor Anti-Angiogenesis Compound) In The Management Of Low To Intermediate Grade Soft Tissue Sarcoma Of The Trunk or 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: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if radiation therapy is more effective with or without SU5416 in treating soft tissue sarcoma. PURPOSE: Phase I/II trial to compare the effectiveness of radiation therapy with or without SU5416 in treating patients who have stage IB or stage IIA soft tissue sarcoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| semaxanib | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary or locally recurrent stage IB or IIA soft tissue sarcoma * Grade 1 or 2 * Tumor greater than 5 cm in diameter * Tumor located on upper extremities (including shoulder), lower extremities (including hip), or body wall * No sarcoma of the head and neck or intra-abdominal or retroperitoneal sarcoma * No desmoid tumor or dermatofibrosarcoma protuberans * No metastatic disease * No evidence of lung metastases * Maximum of 4 lung lesions no greater than 5 mm in diameter each on preoperative chest CT scan allowed OR * Lesion no greater than 1 cm allowed if stable for at least 1 year and fits criteria for granuloma PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-1 Life expectancy: * At least 2 years Hematopoietic: * WBC at least 4,000/mm\^3 OR * Absolute neutrophil count at least 1,800/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 50 U/L * PT and PTT less than 1.25 times normal (not on warfarin) Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 50 mL/min Cardiovascular: * No congestive heart failure or myocardial infarction within the past 6 months * No uncompensated coronary artery disease * No severe peripheral vascular disease * No peripheral vascular disease with diabetes mellitus * No deep venous or arterial thrombosis within the past 3 months * Fibrin split products less than 2 times normal * Fibrinogen greater than 200 mg/dL Pulmonary: * No pulmonary embolism within the past 3 months Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No contraindications to surgery * No active uncontrolled bacterial, viral, or fungal infection * No other prior or concurrent malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer * No other serious medical or psychiatric illness that would preclude informed consent PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy for soft tissue sarcoma Chemotherapy: * No prior chemotherapy for soft tissue sarcoma Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for soft tissue sarcoma Surgery: * At least 2 weeks since prior minor surgery (e.g., port placement) * At least 4 weeks since prior major surgery
References
Publications (0)
Data not yet available