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Clinical Trials (PDQ®)

Phase II Randomized Study of Surgery and Radiotherapy with vs without Neoadjuvant Chemotherapy with DOX/IFF in Adults with Soft Tissue Sarcoma (Summary Last Modified 07/90)

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosed15 to 75EORTC-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 Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Jacques Rouesse, MD, Protocol chair (Contact information may not be current)
Ph: 33-1-47-111-515

NCIC-Clinical Trials Group

Vivien Bramwell, MB, BS, PhD, FRCP, Protocol chair (Contact information may not be current)
Ph: 519-685-8640

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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