Clinical trial · Interventional
Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma
NCT00061984CI-TRIAL-00015909completedPhase 3ClinicalTrials.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 such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| multimodality therapy | Procedure | — | UNRESOLVED |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (3)
- measure
- Response as assessed by RECIST criteria
- measure
- Toxicity as assessed by CTC 2.0
- measure
- Treatment-related mortality
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed soft tissue sarcoma * Locally advanced unresectable\* OR metastatic disease * High-grade (grade 2-3) disease according to the FNLCC grading system NOTE: \*Disease that could prove resectable (including pulmonary metastasectomy) after a response to chemotherapy is allowed * The following tumor types are eligible: * Malignant fibrous histiocytoma * Myxoid and round cell liposarcoma, pleomorphic liposarcoma, or dedifferentiated liposarcoma * Pleomorphic rhabdomyosarcoma * Synovial sarcoma * Myxofibrosarcoma, intermediate and high-grade * Fibrosarcoma * Leiomyosarcoma * Angiosarcoma * Malignant peripheral nerve sheath tumor * Epithelioid sarcoma * Alveolar rhabdomyosarcoma * Unclassifiable sarcoma, not otherwise specified * The following tumor types are not eligible: * Gastrointestinal stromal tumor * Mixed mesodermal tumor * Chondrosarcoma * Malignant mesothelioma * Neuroblastoma * Osteosarcoma * Ewing's sarcoma/primitive neuroectodermal tumor * Desmoplastic small round cell tumor * Embryonal rhabdomyosarcoma * Alveolar soft part sarcoma * Must have a measurable lesion with clinical evidence of progression within the past 6 weeks * Osseous lesions and pleural effusions are not considered measurable * No known or symptomatic CNS metastases PATIENT CHARACTERISTICS: Age * 18 to 60 Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.8 mg/dL * Albumin at least 2.5 g/dL Renal * Creatinine no greater than 1.4 mg/dL OR * Creatinine clearance greater than 65 mL/min Cardiovascular * No history of cardiovascular disease Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No other severe medical illness * No psychosis * No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell skin cancer * No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up schedule PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for advanced or metastatic disease * Prior adjuvant chemotherapy allowed provided there was no disease progression within 6 months after completion of treatment Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to the sole index lesion Surgery * Not specified
References
Publications (1)
- DERIVEDJudson I, Verweij J, Gelderblom H, Hartmann JT, Schoffski P, Blay JY, Kerst JM, Sufliarsky J, Whelan J, Hohenberger P, Krarup-Hansen A, Alcindor T, Marreaud S, Litiere S, Hermans C, Fisher C, Hogendoorn PC, dei Tos AP, van der Graaf WT; European Organisation and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol. 2014 Apr;15(4):415-23. doi: 10.1016/S1470-2045(14)70063-4. Epub 2014 Mar 5. PMID 24618336