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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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival at 3 years

Safety Issue:

No

Principal Investigator

Sean Kehoe

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oxford Radcliffe Hospital

Authority:

Unspecified

Study ID:

CDR0000347463

NCT ID:

NCT00075712

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage IV ovarian epithelial cancer
  • stage IIIA fallopian tube cancer
  • stage IIIB fallopian tube cancer
  • stage IIIC fallopian tube cancer
  • stage IV fallopian tube cancer
  • stage IIIA primary peritoneal cavity cancer
  • stage IIIB primary peritoneal cavity cancer
  • stage IIIC primary peritoneal cavity cancer
  • stage IV primary peritoneal cavity cancer
  • stage IIIA ovarian epithelial cancer
  • stage IIIB ovarian epithelial cancer
  • stage IIIC ovarian epithelial cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

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