Brief Title
Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Official Title
A Randomized Feasibility Trial to Determine the Impact of Timing of Surgery and Chemotherapy in Newly Diagnosed Patients With Advanced Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink
the tumor so that it can be removed; giving chemotherapy after surgery may kill any remaining
tumor cells. It is not yet known whether giving chemotherapy before and after surgery is more
effective than giving chemotherapy after surgery in treating ovarian epithelial, fallopian
tube, or primary peritoneal cavity cancer.
PURPOSE: This randomized phase II/III trial is studying how well giving chemotherapy before
and after surgery works and compares it to giving chemotherapy after surgery alone in
treating patients with newly diagnosed advanced ovarian epithelial, fallopian tube, or
primary peritoneal cavity cancer.
Detailed Description
OBJECTIVES:
- Determine the feasibility of a randomized trial to determine the impact of the timing of
surgery and chemotherapy in patients with newly diagnosed advanced ovarian epithelial,
primary peritoneal, or fallopian tube cancer.
OUTLINE: This is a randomized, pilot, multicenter study. Patients are randomized to 1 of 2
treatment arms.
- Arm I (primary surgery): Patients undergo radical surgery. Within 6 weeks after primary
surgery, patients receive chemotherapy comprising carboplatin alone or in combination
with paclitaxel or another chemotherapy agent on day 1. Chemotherapy repeats every 3
weeks for up to 6 courses in the absence of disease progression or unacceptable
toxicity. Patients may undergo interval debulking surgery after the third course of
chemotherapy.
- Arm II (neoadjuvant chemotherapy): Patients receive chemotherapy as in arm I for 3
courses. Within 3 weeks after chemotherapy, patients undergo radical surgery. Within 6
weeks after surgery, patients receive an additional 3 courses of chemotherapy as in arm
I.
Patients are followed at 9 months after randomization, every 3 months for 2 years, every 6
months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 100-150 patients will be accrued for this study within 18
months.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Overall survival at 3 years
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
150
Start Date
September 2003
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed advanced ovarian epithelial, primary peritoneal, or fallopian tube
cancer
- Clinical and imaging evidence of a pelvic mass with extrapelvic metastases within the
past 4 weeks
- Serum CA 125/CEA ratio > 25
- Plans to receive carboplatin-based chemotherapy
PATIENT CHARACTERISTICS:
Age
- Adult
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Considered fit to undergo protocol treatment and follow-up
- No other prior or concurrent malignancy that would preclude study treatment or
comparisons
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Sean Kehoe, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT00075712
Organization ID
RCOG-MRC-CHORUS
Secondary IDs
CDR0000347463
Study Sponsor
Royal College of Obstetricians and Gynecologists
Study Sponsor
Sean Kehoe, Principal Investigator, Oxford University Hospitals NHS Trust
Verification Date
May 2007