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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	under 75		FRE-FNCLCC-CO-II NCI-F94-0020

Objectives

I.  Determine whether bleomycin/mitomycin/cisplatin/etoposide administered 
prior to pelvic irradiation lowers the incidence of distant relapse and 
improves survival of patients with locally advanced squamous cell carcinoma of 
the cervix compared to pelvic irradiation alone.

Entry Criteria

Disease Characteristics:

Biopsy-proven squamous cell carcinoma of the uterine cervix

Locally advanced disease (UICC and FIGO criteria) required:
  T2b N1 M0 with positive external iliac and/or parametrial
  involvement (Stage IIb)

  T3b N0-1 M0 (Stage IIIb)

No nodal involvement clearly evident on lymphography or CT and
requiring abdominal irradiation
  Doubtful cases are eligible

Unilateral renal involvement allowed provided organ function
parameters are met
  No severe bilateral involvement, even if organ function
  parameters are met

Patients refusing chemotherapy are excluded

Prior/Concurrent Therapy:

No prior therapy (even if incomplete)

Patient Characteristics:

Age:
  Less than 75

Performance status:
  Karnofsky 70-100% (WHO 0-2)

Hematopoietic:
  WBC greater than 4,000
  Platelets greater than 120,000

Hepatic:
  Bilirubin less than 1.1 mg/dl (20 micromoles/liter)

Renal:
  Creatinine less than 1.4 mg/dl (130 micromoles/liter)
  BUN no greater than 28 mg/dl (10 mmoles/liter)

Other:
  No severe bleeding disorder
  No other severe medical condition that would limit life
     expectancy
  No other active malignancy except basal cell skin carcinoma
  No psychological, familial, or socioeconomic contraindication
     to follow-up

Expected Enrollment

180 patients will be accrued over 3 years.

Outline

Randomized study.

Arm I:  4-Drug Combination Chemotherapy followed by Radiotherapy.  Bleomycin, 
BLEO, NSC-125066; Mitomycin, MITO, NSC-26980; Cisplatin, CDDP, NSC-119875; 
Etoposide, VP-16, NSC-141540; followed by pelvic irradiation using megavoltage 
photons (10-25 MV), followed by a boost using external-beam irradiation or 
brachytherapy (Cesium-137 or Iridium-192).

Arm II:  Radiotherapy.  Pelvic irradiation as in Arm I.

Trial Contact Information

Trial Lead Organizations

Federation Nationale des Centres de Lutte Contre le Cancer

Jacques Chauvergne, MD, Protocol chair(Contact information may not be current)		Ph: 33-556-333-333