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LAPAROSCOPIC STAGING IN PATIENTS WITH INCOMPLETELY STAGED CANCERS OF THE OVARY


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

LAPAROSCOPIC STAGING IN PATIENTS WITH INCOMPLETELY STAGED CANCERS OF THE OVARY


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Nick M. Spirtos, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Women's Cancer Center - Palo Alto

Authority:

United States: Federal Government

Study ID:

CDR0000078530

NCT ID:

NCT00002538

Start Date:

September 1993

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • 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
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Vincent T. Lombardi Cancer Research Center, Georgetown UniversityWashington, District of Columbia  20007
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Women's Cancer CenterPalo Alto, California  94304