Clinical trial · Interventional
Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Primary or Recurrent Sarcoma
Phase II Study of Neoadjuvant Doxorubicin and Ifosfamide, Radiotherapy, and Surgical Resection in Patients With Primary or Recurrent Retroperitoneal Sarcoma
NCT00017160CI-TRIAL-00011143withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and surgery in treating patients who have primary or recurrent sarcoma.
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 |
|---|---|---|---|
| Recurrent Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage IIB Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage IIC Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage III Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage IVA Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biological response modifier therapy | Procedure | — | UNRESOLVED |
| brachytherapy | Procedure | — | UNRESOLVED |
| chemotherapy | Procedure | — | UNRESOLVED |
| colony-stimulating factor therapy | Procedure | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| cytokine therapy | Procedure | — | UNRESOLVED |
| doxorubicin | Drug | Doxorubicin | ALIAS |
| filgrastim | Drug | Filgrastim | ALIAS |
| ifosfamide |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary or recurrent soft tissue sarcoma of the retroperitoneum or pelvis * No rhabdomyosarcoma, extraosseous Ewing's sarcoma, primitive neuroectodermal tumor, osteosarcoma, chondrosarcoma, Kaposi's sarcoma, or aggressive fibromatosis * No sarcoma that does not allow sparing of two-thirds of 1 kidney within planned irradiation field * Radiographically measurable disease greater than 5 cm (T2) by CT scan or MRI of the abdomen and pelvis * High-grade (grade 3/3, 3/4, 4/4) disease greater than 5 cm OR * Moderate-grade (grade 2/3, 2/4) recurrent disease greater than 10 cm * Eligible for gross total resection (R0 or R1) * No prior subtotal (R2) resection * Partial debulking OR subtotal tumor resection with residual gross disease * Fewer than 4 equivocal pulmonary lesions each less than 3 mm in diameter by CT scan * No multifocal disease suggestive of regional nodal involvement * No metastases PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-2 Life expectancy: * At least 2 years Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST no greater than 3 times upper limit of normal * Albumin at least 3.5 g/dL Renal: * Creatinine no greater than 1.6 mg/dL * Two functional kidneys Cardiovascular: * No congestive heart failure * No myocardial infarction within the past 6 months * No New York Heart Association class III or IV heart disease * Ejection fraction at least 50% Other: * No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * No serious medical or psychiatric illness that would preclude study entry * No obvious bowel obstruction * No hypersensitivity to E. coli-derived products * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Oral caloric intake at least 1,500 kCal/day PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior doxorubicin or ifosfamide * No prior chemotherapy for sarcoma Endocrine therapy: * Not specified Radiotherapy: * No prior abdominal or pelvic irradiation Surgery: * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.