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

November 1, 1999
August 19, 2013
September 1993
March 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00002538 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Laparoscopic Staging in Patients With Ovarian, Fallopian Tube, or Other Primary Abdominal Cancers
LAPAROSCOPIC STAGING IN PATIENTS WITH INCOMPLETELY STAGED CANCERS OF THE OVARY

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
Procedure: laparoscopic surgery
Not Provided
Spirtos NM, Eisekop SM, Boike G, Schlaerth JB, Cappellari JO. Laparoscopic staging in patients with incompletely staged cancers of the uterus, ovary, fallopian tube, and primary peritoneum: a Gynecologic Oncology Group (GOG) study. Am J Obstet Gynecol. 2005 Nov;193(5):1645-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
March 2010   (final data collection date for primary outcome measure)

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

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002538
GOG-9302, CDR0000078530
Yes
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Nick M. Spirtos, MD Women's Cancer Center - Palo Alto
Gynecologic Oncology Group
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP