Ovarian Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS: One of the following incompletely staged malignancies: Ovarian cancer of any cell type Primary fallopian tube carcinoma Primary peritoneal carcinoma No clinical evidence of metastases to abdominal organs, the adnexa, or retroperitoneal lymph nodes on CT with contrast or at prior abdominal surgery No metastases on chest x-ray No contraindications to laparoscopy, i.e.: No bowel obstruction No ileus No peritonitis No excessive obesity as indicated by a Quetelet Index over 35 (weight in kg/height in sqm) No diaphragmatic hernia on chest x-ray No grade 2 heart toxicity

PATIENT CHARACTERISTICS: Age: Adult Performance status: GOG 0 or 1 Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no more than 1.5 mg/dL AST no more than 3 times normal Renal: Creatinine no more than 2.0 mg/dL Other: No second malignancy except nonmelanomatous skin cancer Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or concomitant chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior or concomitant abdominal or pelvic radiotherapy Surgery: No prior retroperitoneal surgery No more than 10 weeks since initial abdominal surgery

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00002538

Recruitment Status:

Completed

Sponsor:

Gynecologic Oncology Group

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There are 11 Locations for this study

See Locations Near You

USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
Women's Cancer Center
Palo Alto California, 94304, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington District of Columbia, 20007, United States
Walter Reed Army Medical Center
Washington District of Columbia, 20307, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago Illinois, 60612, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
University of Oklahoma College of Medicine
Oklahoma City Oklahoma, 73190, United States
Abington Memorial Hospital
Abington Pennsylvania, 19001, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00002538

Recruitment Status:

Completed

Sponsor:


Gynecologic Oncology Group

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