Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

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

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