NCT00949039

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 12, 2015

Status Verified

March 1, 2015

Enrollment Period

5.1 years

First QC Date

July 7, 2009

Last Update Submit

March 11, 2015

Conditions

Gynaecologic or Digestive Pelvic Cancer

Outcome Measures

Primary Outcomes (1)

  • Survival rate

    From randomization to death

Study Arms (2)

Chemotherapy

EXPERIMENTAL

Isolated pelvis perfusion

Drug: Isolated pelvis perfusion

Control

ACTIVE COMPARATOR

Standard treatment

Radiation: radiotherapyProcedure: Surgery

Interventions

Isolated pelvis perfusionDRUG

injection of TNF-α 0.3 mg followed 5 minutes later by melphalan 1,5mg/kg

Chemotherapy
radiotherapyRADIATION

chemotherapy and/or radiotherapy and/or surgery

Control
SurgeryPROCEDURE
Control

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94800, France

Location

Related Links

MeSH Terms

Interventions

RadiotherapySurgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 30, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 12, 2015

Record last verified: 2015-03

Locations

FR(1)