Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | 15 to 75 | EORTC-62874 CAN-NCIC-SR1, SR1 |
Objectives
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.
Entry Criteria
Disease Characteristics:
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
Prior/Concurrent Therapy:
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
Patient Characteristics:
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
Expected Enrollment
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.
Outline
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) | |
| |
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NCIC-Clinical Trials Group
| | | |
| 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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