Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Debulking Surgery in Ovarian Cancer

NCT03378128

Malignant Neoplasm of Ovary Malignant Neoplasm of Fallopian Tube Malignant Neoplasm of Peritoneum

COMPLETED NA

Tolerance of Intraperitoneal (IP) Nivolumab After Extensive Debulking Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Ovarian Carcinoma

NCT03959761

Ovarian Cancer

COMPLETED PHASE1/PHASE2

Microscopic Peritoneal Metastases After Complete Macroscopic Cytoreductive Surgery for Epithelial Ovarian Cancer

NCT03754569

Epithelial Ovarian Cancer

COMPLETED NA

Intraperitoneal Hyperthermic Chemotherapy in Epithelial Ovarian Carcinoma

NCT00349505

Epithelial Ovarian Carcinoma Figo Stage IIIC

UNKNOWN PHASE2

A Phase II Combined Modality Protocol of Debulking Surgery With HIPEC Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal & Fallopian Tube Cancers

NCT01659554

Recurrent Ovarian Cancer Fallopian Tube Cancer

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer Fallopian Tube Cancer Peritoneal Cavity Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

laparoscopic management

Tumor Debulking Surgery by laparoscopy

Group Type EXPERIMENTAL

Tumor Debulking Surgery by laparoscopy

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tumor Debulking Surgery by laparoscopy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No