Pelvic and Aortic-cava Lymphadenectomy Randomized for Ova... | NCT01218490

Studies
Pelvic and Aortic-cava Lymphadenectomy Randomized for Ovarian Cancer

NCT01218490

Sponsor

Institut Cancerologie de l'Ouest

Status

Suspended

Last Update Posted

May 16, 2019Actual

Enrollment

450Estimated

Phase

Phase 3

Conditions

Ovarian Cancer

Interventions

ovarian cancer surgery

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

qualitative analysis of the study database

Expanded Access Info

Start Date

Dec 9, 2008Actual

Primary Completion Date

May 2026Estimated

Completion Date

May 2026Estimated

First Submitted Date

Oct 8, 2010

First Submission Date that Met QC Criteria

Oct 8, 2010

First Posted Date

Oct 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2019

Last Update Posted Date

May 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

It is a multicenter randomized trial of superior cleaning compared the absence of dissection in stage III patients with optimal surgical resection without retroperitoneal lymph node palpable.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

450Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lymphadenectomy	Experimental	after surgery of the ovarian cancer, patient will have Pelvis and aortic-cava lymphadenectomy	Procedure: ovarian cancer surgery
no lymphadectomy	No Intervention	after surgery, the patient will not have pelvic and aortic-cave lymphadenectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ovarian cancer surgery	Procedure		lymphadenectomy

Measure	Description	Time Frame
survival with out recurrence		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age> 18 years
Karnofsky> 80, or ASA I-II
Primary ovarian adenocarcinoma, or primitive peritoneal
No retroperitoneal lymph node> 2cm (CT; MRI)
Complete surgical staging
Stage III-IV FIGO classification
Indication of systemic chemotherapy before surgery or post surgery

Exclusion Criteria:

Non Invasive Cancer
non-epithelial or borderline cancer
Pregnancy
Previous pelvic lymphadenectomy or aortic-cava for a disease other than ovarian cancer
Contraindication to Platinum and Paclitaxel
Borderline Ovarian Tumor
tumor recurrence
Incomplete surgery, resectable lesion, Surgery sub optimal (R> 1cm)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Sainte Thérèse		Amiens		80000	France
Centre Paul Papin

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided