NCT01905163

Brief Summary

This prospective nonrandomized multicenter phase II study, will evaluate the possibility of performing a laparoscopic interval debulking after a minimum of 3 cycles of chemotherapy in highly chemo-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Timeline
Completed

Started Aug 2013

Typical duration for phase_2 ovarian-cancer

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

July 9, 2013

Last Update Submit

July 18, 2017

Conditions

Ovarian CancerFallopian Tube CancerPeritoneal Cavity Cancer

Keywords

Laparoscopy, interval debulking surgery

Outcome Measures

Primary Outcomes (1)

  • the rate of conversion to laparotomy

    Feasibility of the surgical laparoscopic management of interval debulking surgery will be assessed by the rate of conversion to laparotomy.

    surgery

Secondary Outcomes (5)

  • Port site metastases

    during 1 year post surgery

  • Morbidity: intraoperative and postoperative complications

    during surgery and 1 year post surgery

  • Pain

    during the hospital stay (an expected average of 5 days), at 1 week, 1 month, 3 and 6 months post surgery

  • Quality of life using EORTC QLQ-C30

    before surgery (an expected average of 7 days before surgery), 1 week , 1 month, 3 and 6 months post-surgery

  • Economic evaluation

    1 year post-surgery

Study Arms (1)

laparoscopic management

EXPERIMENTAL

Tumor Debulking Surgery by laparoscopy

Procedure: Tumor Debulking Surgery by laparoscopy

Interventions

Tumor Debulking Surgery by laparoscopyPROCEDURE
laparoscopic management

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> or = 18 years
  • performance status WHO \< 2
  • Epithelial ovarian, fallopian tubes or primary peritoneal carcinoma (histologically confirmed)
  • Unresectable disease because of FIGO stage IV disease proven by imaging (CT Scan or PET CT) and/or diffuse extensive carcinosis considered unresectable for advanced FIGO stage IIIc; or patients unable to support a radical primary surgery because of age, comorbidities or altered general condition.
  • No previous debulking surgery before neoadjuvant chemotherapy.
  • Patients treated with a minimum of 3 cycles of platinum-based neoadjuvant chemotherapy.
  • Response to chemotherapy was radiologically confirmed (Scan-TAP) prior to interval surgery:
  • No evidence of peritoneal supra-mesocolic carcinomatosis ; Residual pelvic masses smaller than 10 cm ; Absence of suspect supra-centimeter retroperitoneal lymphadenopathy
  • able to read, write and understand French.
  • Member of a Social Security scheme.
  • written informed consent.

You may not qualify if:

  • Patient unable to support laparoscopy
  • psychiatric condition or social or geographic situation that would impede appropriate study participation
  • Concomitant participation in another clinical trial evaluating surgical treatment (interfering with the evaluation of the main endpoint)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Institut de Cancerologie de l'Ouest, site Paul Papin

Angers, 49100, France

Location

CHU Estaing

Clermont-Ferrand, 63003, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Institut Paoli Calmettes

Marseille, 13009, France

Location

Institut Curie

Paris, 75005, France

Location

Hôpital Européen Georges-Pompidou

Paris, 75015, France

Location

Institut Curie - Hôpital René Huguenin

Saint-Cloud, 92210, France

Location

Institut de Cancérologie de L'Ouest

Saint-Herblain, 44805, France

Location

Hôpital de Hautepierre

Strasbourg, 67000, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Officials

  • Christophe POMEL, Pr

    Centre Jean Perrin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 23, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2016

Study Completion

July 1, 2017

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

FR(10)