Phase III Surgery with vs without Adjuvant Chemotherapy with ADR/DTIC/CTX/VCR for Nonmetastatic Soft Tissue Sarcoma
Basic Trial Information
|Phase III||Treatment||Closed||15 to 70||EORTC-62771|
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.
See General Eligibility Criteria
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.
An accrual of 210 patients is anticipated.
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.
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 Contact Information
Trial Lead Organizations
European Organization for Research and Treatment of Cancer
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