|Phase II||Treatment||Closed||15 to 75||EORTC-62874|
I. Determine the rate of accrual to this trial and the feasibility of neoadjuvant chemotherapy with doxorubicin/ifosfamide followed by surgery and postoperative radiotherapy in patients with soft tissue sarcoma who have a high risk factor in order to determine whether it is possible to carry out a Phase III trial. II. Compare the duration of the disease-free interval (without metastases and local recurrence) and survival in each group of patients.
Histologically evident soft tissue sarcoma of a limb, head and neck, trunk, or pelvis for which adequate removal of tumor by definitive operation is considered possible Biopsy-proven disease required prior to randomization No evidence of metastases at distant sites or in regional lymph nodes No uterine, retroperitoneal, or visceral intra-abdominal (e.g., stomach) tumor The following cell types are included: Malignant fibrous histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Clear cell sarcoma Hemangiopericytoma Fibrosarcoma Leiomyosarcoma Angiosarcoma Neurogenic sarcoma Unclassified sarcoma Miscellaneous sarcoma The following cell types are specifically excluded: Extraosseous Ewing's sarcoma Osteosarcoma Chondrosarcoma Kaposi's sarcoma Embryonal rhabdomyosarcoma Malignant mesothelioma Sarcoma secondary to radiotherapy One of the following high-risk factors is required: Tumor larger than 8 cm that is any histologic type or grade Tumor smaller than 8 cm that is Grade II/III and any histologic type Inadequately resected tumor (e.g., excisional biopsy) within previous 6 weeks that is Grade II/III and any histologic type for which further surgery is necessary Local recurrence (Grade II/III) previously treated by surgery only
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No more than 1 prior operation unless tumor is Grade II/III and in first local recurrence No prior amputation or other definitive operation No infected wound or problem resulting from first surgery that would prevent immediate treatment
Age: 15 to 75 Performance status: WHO 0 or 1 Hematopoietic: WBC greater than 4,000 OR AGC greater than 2,500 Platelets greater than 120,000 Hepatic: Not specified Renal: Creatinine less than 1.32 mg/dl (120 micromoles/liter) Creatinine clearance greater than 50 ml/min Cardiovascular: No history of cardiovascular disease Other: No other severe medical illness (including psychoses) No second malignancy other than: Adequately treated carcinoma in situ of the cervix Adequately treated basal cell carcinoma
A minimum of 60 patients per year will be required; after 1 year a decision will be made concerning the feasibility of expanding the trial into a Phase III study of approximately 300 patients.
Randomized study. Arm I: 2-Drug Combination Chemotherapy with Urothelial Protection plus Surgery plus Radiotherapy. Doxorubicin, Adriamycin, DOX, NSC-123127; Ifosfamide, IFF, NSC-109724; with Mesna, NSC-113891; plus radical excision of tumor; plus irradiation of the whole operated area using megavoltage external beam equipment (boost dose may be given with interstitial implants). Arm II: Surgery plus Radiotherapy. Radical surgery; plus irradiation as in Arm I.Published Results
Gortzak E, Azzarelli A, Buesa J, et al.: A randomised phase II study on neo-adjuvant chemotherapy for 'high-risk' adult soft-tissue sarcoma. Eur J Cancer 37 (9): 1096-103, 2001.[PUBMED Abstract]
Trial Lead Organizations
European Organization for Research and Treatment of Cancer
|Jacques Rouesse, MD, Protocol chair (Contact information may not be current)|
NCIC-Clinical Trials Group
|Vivien Bramwell, MB, BS, PhD, FRCP, Protocol chair (Contact information may not be current)|
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.