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

LAPAROSCOPIC STAGING IN PATIENTS WITH INCOMPLETELY STAGED CANCERS OF THE OVARY

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002538

Enrollment

Unknown

Registered

2004-06-10

Start date

1993-09-30

Completion date

Unknown

Last updated

2013-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Keywords

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

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.

Interventions

PROCEDURElaparoscopic surgery

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026