Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Not specified	Other	EORTC-55971 NCT00003636

Objectives

1. Compare the overall survival and progression-free survival in patients with stage IIIC or IV ovarian epithelial, peritoneal, or fallopian tube carcinoma treated with neoadjuvant chemotherapy followed by interval debulking surgery versus upfront cytoreductive surgery followed by chemotherapy with or without interval debulking surgery.
2. Compare the quality of life of patients treated with these regimens.
3. Compare the different treatment complications in patients treated with these regimens.

Entry 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

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

Patient Characteristics:

Age:

• Not specified

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,000/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

A total of 704 patients will be accrued for this study within 4 years.

Outcomes

Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually

Progression-free survival as measured by Kaplan Meier and RECIST every 3 months for 2 years, every 6 months for 3 years, and then annually
Health-related quality of life as measured by Quality of Life Questionnaire-C30 after courses 1, 3 and 6, then at 6 and 12 months
Toxicity as measured by NCIC Common Toxicity Criteria v2.0 within 4 weeks of surgery

Outline

This is a randomized, multicenter study. Patients are stratified according to participating center, method of biopsy, stage, largest tumor size before surgery, and intent to also randomize on EORTC-55012. Patients are randomized to one of two treatment arms.

• Arm I: Patients undergo upfront maximal cytoreductive surgery followed by cisplatin or carboplatin IV every 3 weeks for 3 courses. Patients with non-optimal primary debulking may undergo interval debulking surgery at the physician's discretion. All patients then receive an additional 3 courses of the same regimen of chemotherapy.



• Arm II: Patients receive chemotherapy as in arm I. Patients with stable or responding disease undergo interval debulking surgery followed by an additional 3 courses of the same regimen of chemotherapy.

Second-look surgery is allowed for both arms if clinically indicated.

Quality of life (QOL) is assessed prior to treatment, after the third and sixth course of chemotherapy, and at 6 and 12 months after study. Patients who are also randomized on EORTC-55012 follow the QOL assessment schedule for EORTC-55012 only.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Fruehauf JP, Yu I, Parker R: In vitro drug response and biomarker profiles for ovarian cancer specimens obtained at initial debulking or after neoadjuvant chemotherapy (EORTC 55971). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2177, 2002.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Ignace Vergote, MD, PhD, Study coordinator		Ph: 31-16-344-635

Related Information

PDQ® clinical trial CAN-NCIC-OV16

Registry Information
Official Title		A Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients with Stage IIIC or IV Epithelial Ovarian Carcinoma
Trial Start Date		1998-09-21
Registered in ClinicalTrials.gov		NCT00003636
Date Submitted to PDQ		1998-10-14
Information Last Verified		2006-11-19