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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00002538
First received: November 1, 1999
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Procedure: laparoscopic surgery
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: LAPAROSCOPIC STAGING IN PATIENTS WITH INCOMPLETELY STAGED CANCERS OF THE OVARY

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Study Start Date: September 1993
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002538

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
Women's Cancer Center
Palo Alto, California, United States, 94304
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington, District of Columbia, United States, 20007
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Nick M. Spirtos, MD Women's Cancer Center - Palo Alto
  More Information

Additional Information:
Publications:
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00002538     History of Changes
Other Study ID Numbers: GOG-9302, CDR0000078530
Study First Received: November 1, 1999
Last Updated: August 19, 2013
Health Authority: United States: Federal Government
United States: National Cancer Institute

Keywords provided by Gynecologic Oncology Group:
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
ovarian undifferentiated adenocarcinoma
ovarian mixed epithelial carcinoma
ovarian serous cystadenocarcinoma
ovarian mucinous cystadenocarcinoma
ovarian endometrioid adenocarcinoma
ovarian clear cell cystadenocarcinoma
fallopian tube cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases

ClinicalTrials.gov processed this record on September 30, 2014