Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Closed | 15 to 70 | EORTC-62771 |
Objectives
I. Study chemotherapy with adriamycin, DTIC, cyclophosphamide, and vincristine as an adjunct to surgery in the management of soft tissue sarcoma of the extremities and of the head and neck region (and trunk, per January 1979 revision). II. Compare the duration of the disease-free interval and survival in the group of patients being treated for 8 months and the patients given no chemotherapy.
Entry Criteria
Disease Characteristics:
See General Eligibility Criteria
Patient Characteristics:
See General Eligibility Criteria
General Eligibility Criteria:
Patients 20 to 70 (15 to 70 per January 1979 revision) years of age with histologically proven, nonmetastatic soft tissue sarcoma that has been totally excised within 13 weeks of study entry. The following histologic types are eligible: fibrosarcoma, liposarcoma, leiomyosarcoma, rhabdomyosarcoma, malignant hemangioendothelioma (angiosarcoma), malignant lymphangiopericytoma, malignant lymphangioendothelioma (lymphangiosarcoma), malignant synovioma, malignant Schwannoma (neurofibrosarcoma), malignant mesenchymoma, alveolar soft-parts sarcoma, malignant granular cell tumor, chondrosarcoma of soft parts, osteosarcoma of soft parts, malignant giant-cell tumor of soft parts, malignant fibroxanthoma, and clear-cell sarcomas of tendons and aponeuroses. Patients must have adequate hematological and hepatic function and have had no prior preoperative radiotherapy nor chemotherapy nor macroscopic disease after tumor excision and no history of other malignant disease except skin cancer. Patients with any form of heart disease (excluding asymptomatic minor EKG changes) or any serious infection are excluded. Per January 1979 revision, patients with microscopically proven lymph node involvement are ineligible.
Expected Enrollment
An accrual of 210 patients is anticipated.
Outline
Randomized study. Patients are randomized within 13 weeks of primary surgery or of resection of recurrent tumor. Arm I: 4-Drug Combination Chemotherapy. Adriamycin, ADR, NSC-123127; DTIC, NSC-45388; Cyclophosphamide, CTX, NSC-26271; Vincristine, VCR, NSC-67574. Arm II: No Chemotherapy.Related Publications
Kasper B, Ouali M, van Glabbeke M, et al.: Prognostic factors in adolescents and young adults (AYA) with high risk soft tissue sarcoma (STS) treated by adjuvant chemotherapy: a study based on pooled European Organisation for Research and Treatment of Cancer (EORTC) clinical trials 62771 and 62931. Eur J Cancer 49 (2): 449-56, 2013.[PUBMED Abstract]
Le Cesne A, Van Glabbeke M, Woll PJ, et al.: The end of adjuvant chemotherapy (adCT) era with doxorubicin-based regimen in resected high-grade soft tissue sarcoma (STS): pooled analysis of the two STBSG-EORTC phase III clinical trials. [Abstract] J Clin Oncol 26 (Suppl 15): A-10525, 2008.
Trial Lead Organizations
European Organization for Research and Treatment of Cancer
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| Vivien Bramwell, MB, BS, PhD, FRCP, Protocol chair (Contact information may not be current) | |
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Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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