Brief Title
Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer
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
Brief 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.
Detailed Description
OBJECTIVES:
- 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.
- Compare the quality of life of patients treated with these regimens.
- Compare the different treatment complications in patients treated with these regimens.
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.
PROJECTED ACCRUAL: A total of 704 patients will be accrued for this study within 4 years.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually
Secondary Outcome
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
Condition
Fallopian Tube Cancer
Intervention
carboplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
704
Start Date
September 1998
Primary Completion Date
January 2009
Eligibility 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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Ignace B. Vergote, MD, PhD, ,
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT00003636
Organization ID
EORTC-55971
Secondary IDs
EORTC-55971
Responsible Party
Sponsor
Study Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor
Ignace B. Vergote, MD, PhD, Study Chair, U.Z. Gasthuisberg, Leuven
Verification Date
August 2013