Study Comparing Isolated Pelvic Perfusion With TNF-α 0.3... | NCT00949039

ID	Type	Description	Link
CSET 1443

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Jul 7, 2009

First Submission Date that Met QC Criteria

Jul 29, 2009

First Posted Date

Jul 30, 2009Estimated

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

Mar 11, 2015

Last Update Posted Date

Mar 12, 2015Estimated

Description Module

Brief Summary

Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery).

Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer.

The aim of the study is to show a 25% increase in 1 year overall survival rate with isolated pelvic perfusion.

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

101Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chemotherapy	Experimental	Isolated pelvis perfusion	Drug: Isolated pelvis perfusion
Control	Active Comparator	Standard treatment	Radiation: radiotherapy Procedure: Surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Isolated pelvis perfusion	Drug	injection of TNF-α 0.3 mg followed 5 minutes later by melphalan 1,5mg/kg	Chemotherapy

Measure	Description	Time Frame
Survival rate		From randomization to death

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically proved locally advanced gynaecologic or digestive tumours (epidermoid carcinomas, adenocarcinomas, neuroendocrine tumours, sarcomas or melanomas), (cervix, vagina, rectal, anal).
Locally recurrent tumours for which surgical treatment will be mutilating or marginal (R1 or R2) and/or for cervix cancer, primary tumours non accessible for standard treatment (radiotherapy- chemotherapy - brachytherapy and surgery).
Surgically resectable tumour (R0 type) but for which patient does not agree with surgery.
Patients aged over 18 and under 76 ans
Performance OMS Index ≤ 2
Normal biologic parameters
Good general and cardiac state (ASA I or II and NYHA I or II)

Exclusion Criteria:

Surgically resectable tumour (RO) or peritoneal tumour extension or distant metastasis.
Cardiac or vascular pathology
Pulmonary disease
Uncontrolled Sepsis disease
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

76 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave Roussy		Villejuif		94800	France

Label	URL
Related Info	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D011878	Radiotherapy
D013514	Surgical Procedures, Operative