Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer

Overall Survival Clinical Trial

Official title:

Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer: a Prospective Validation and Comparison With Open Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02980185
• Other study ID #: 541
• Status: Completed
• Phase: N/A
• First received: November 26, 2016
• Last updated: November 29, 2016
• Start date: June 2007
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

To assess the feasibility, Residual Tumor, complication rate and survival of totally laparoscopic primary cytoreduction in carefully selected patients with Advanced Ovarian Cancer, compared with abdominal primary cytoreduction in a single-Institution, single-surgeon prospective series.

Description:

All patients with presumed stage III-IV ovarian cancer and clinical conditions allowing aggressive surgery were candidate to possible primary cytoreduction with the aim of achieving residual tumor=0. A definite protocol was adopted: after radiological preoperative evaluation with PET-CT scan, all patients underwent laparoscopic evaluation with the Fagotti score. Once considered suitable for primary debulking surgery, the possibility of attempting laparoscopic cytoreduction was carefully evaluated using strict selection criteria; patients were divided in two groups, based on the type of surgical approach. At the end of laparoscopic primary cytoreduction, a ultra-low pubic minilaparotomy was performed to extract surgical specimens and to perform laparoscopic hand-assisted exploration of the abdominal organs, in order to ensure complete excision of the disease. Surgical data, optimal cytoreduction (defined as residual tumor=0) rates and survival outcomes were investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Primary Ovarian cancer

• Epithelial histotype

• Stage III-IV disease

Exclusion Criteria:

• Anesthesiological contraindication to primary cytoreduction

• Extension of disease contraindicating primary cytoreduction

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease-free Survival
• Neoplasm, Residual
• Ovarian Neoplasms
• Overall Survival
• Residual Tumor

Intervention

Procedure:
• Laparoscopic primary cytoreduction
Primary cytoreduction for ovarian cancer performed through a completely minimally-invasive approach

Locations

Country	Name	City	State
Italy	Department of Obstetrics and Gynecology Universita' Dell'Insubria	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Nezhat FR, DeNoble SM, Liu CS, Cho JE, Brown DN, Chuang L, Gretz H, Saharia P. The safety and efficacy of laparoscopic surgical staging and debulking of apparent advanced stage ovarian, fallopian tube, and primary peritoneal cancers. JSLS. 2010 Apr-Jun;14(2):155-68. doi: 10.4293/108680810X12785289143990. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual tumor at the end of surgery (using the completeness of cytoreduction score)		June 2007 - July 2015	No
Secondary	Disease-free Survival		June 2007 - July 2016	No
Secondary	Overall Survival		June 2007 - July 2016	No