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

Gustave Roussy

Status and phase: Completed; Phase 3

Conditions: Gynaecologic or Digestive Pelvic Cancer

Treatments: Procedure: Surgery; Drug: Isolated pelvis perfusion; Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00949039

CSET 1443

PIP2

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

101 participants in 2 patient groups

Chemotherapy

Experimental group

Description:

Isolated pelvis perfusion

Treatment:

Drug: Isolated pelvis perfusion

Control

Active Comparator group

Description:

Standard treatment

Treatment:

Radiation: radiotherapy

Procedure: Surgery