Laparoscopic Staging in Patients With Ovarian, Fallopian Tube, or Other Primary Abdominal Cancers

Phase 2

Completed

• Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

• Registration Number: NCT00002538
• Lead Sponsor: Gynecologic Oncology Group

Brief Summary

RATIONALE: Laparoscopic staging may help doctors plan more effective treatment for ovarian, primary fallopian tube, and primary abdominal cancers.

PURPOSE: Phase II trial to study the effectiveness of laparoscopic staging in patients with ovarian, primary fallopian tube, or primary abdominal cancers who have not undergone complete staging.

Detailed Description

OBJECTIVES: I. Determine the feasibility of laparoscopic staging of patients with incompletely staged ovarian, primary fallopian tube, and primary peritoneal cancers. II. Assess the adverse effects associated with this technique.

OUTLINE: Surgery. Laparoscopy with cytologic examination and lymph node sampling followed, if feasible, by surgical resection.

PROJECTED ACCRUAL: Up to 50 patients will be accrued over approximately 2 years. If more than 4 evaluable patients cannot complete surgery, the study will be closed.

Study Timeline

• Study Start: 1993-09
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-06-09
• Study First Posted: 2004-06-10
• Primary Completion: 2010-03
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-19
• Last Update Posted: 2013-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (11)

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Rush-Presbyterian-St. Luke's Medical Center; 🇺🇸 Chicago, Illinois, United States

Vincent T. Lombardi Cancer Research Center, Georgetown University; 🇺🇸 Washington, District of Columbia, United States

University of Minnesota Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

University of Oklahoma College of Medicine; 🇺🇸 Oklahoma City, Oklahoma, United States

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States

Women's Cancer Center; 🇺🇸 Palo Alto, California, United States

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States

Abington Memorial Hospital; 🇺🇸 Abington, Pennsylvania, United States