Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy before surgery is more effective than chemotherapy after surgery in treating ovarian, peritoneal, or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy given before surgery to see how well it works compared to chemotherapy given after surgery with or without additional surgery in treating patients with stage III or stage IV ovarian cancer, peritoneal cancer, or fallopian tube cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Carboplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven stage IIIC or IV ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma

• If biopsy is not available, evidence of adenocarcinoma by fine needle aspiration allowed if all of the following are true:

• Presence of pelvic ovarian mass

• Omental cake or other metastasis larger than 2 cm in the upper abdomen and/or regional lymph node metastasis

• CA 125/carcinoembryonic antigen ratio greater than 25 (if ratio less than 25, barium enema or colonoscopy AND gastroscopy or radiological examination of the stomach must be negative for primary tumor)

• Normal mammography (if CA 125/carcinoembryonic antigen ratio less than 25)

• Tumor greater than 2 cm, excluding ovaries, on laparoscopy or CT scan

• No brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,000/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin less than 1.25 times upper limit of normal (ULN)

Renal:

• Creatinine less than 1.25 times ULN

Other:

• No other serious disabling diseases contraindicating primary cytoreductive surgery or primary platin-based chemotherapy

• No other prior primary malignancies except carcinoma in situ of the cervix or basal cell carcinoma of the skin

• No psychological, familial, sociological, or geographical condition potentially preventing protocol compliance or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• No other prior procedures except diagnostic biopsy by laparotomy or laparoscopy