Study Comparing Isolated Pelvic Perfusion With TNF-α 0.3 mg and Melphalan 1.5 mg/kg Versus Standard Treatment in Patients With Non Resectable, Recurrent Gynaecologic or Digestive Pelvic Cancer

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00949039

Enrollment

101

Registered

2009-07-30

Start date

2009-02-28

Completion date

2014-03-31

Last updated

2015-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynaecologic or Digestive Pelvic Cancer

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.

Interventions

DRUGIsolated pelvis perfusion

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

RADIATIONradiotherapy

chemotherapy and/or radiotherapy and/or surgery

PROCEDURESurgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 76 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Survival rate	From randomization to death

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026