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Randomized Trial on Chemosensitivity Testing in Advanced Primary Ovarian Carcinoma (Phase III)

Phase 3
80 Years
Not Enrolling
Ovarian Cancer

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Trial Information

Randomized Trial on Chemosensitivity Testing in Advanced Primary Ovarian Carcinoma (Phase III)

OBJECTIVES: I. Determine whether the use of a chemosensitivity assay to assign treatment
improves the time to progression and response rates of patients with stage III/IV ovarian

OUTLINE: This is a randomized study. Patients are stratified according to size of tumor
after debulking surgery, stage, and Swiss Group for Clinical Cancer Research center where
treatment is received. Within 14 days after patients undergo debulking surgery, they are
randomized to one of two treatment arms. Arm I: Patients randomized to this arm receive one
of six treatment regimens: Regimen A - cisplatin/cyclophosphamide Regimen B -
cisplatin/cyclophosphamide/doxorubicin Regimen C - carboplatin Regimen D -
carboplatin/cyclophosphamide Regimen E - cisplatin/paclitaxel Regimen F -
carboplatin/paclitaxel Arm II: Patients who are randomized to this arm are assigned a
treatment regimen based on a chemosensitivity assay of tumor specimens collected after
debulking surgery. If no valid assay result is obtained, patients receive
carboplatin/cyclophosphamide. Treatment is repeated every 3-4 weeks for a total of 6
courses. Up to 4 more courses may be administered if a partial response is demonstrated.
Patients are followed every 3 months for the first 2 years and every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 300 patients will be accrued for this study over 6 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically/pathologically confirmed stage III and IV ovarian
cancer Complete surgical staging and debulking including total abdominal hysterectomy,
bilateral salpingo-oophorectomy, omentectomy, and biopsies of suspicious lesions (if
feasible) required No low malignant potential histology without any invasive lesions in
the peritoneum

PATIENT CHARACTERISTICS: Age: 80 and under Performance status: 0-3 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other:
No disorder that would prevent the application of any protocol treatment

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

O.R. Kochli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Frauenspital, Basel


Switzerland: Swissmedic

Study ID:

SAKK 45/94



Start Date:

July 1996

Completion Date:

April 2000

Related Keywords:

  • Ovarian Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • Ovarian Neoplasms