Clinical trial · Interventional
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
NCT00949039CI-TRIAL-00017127completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynaecologic or Digestive Pelvic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Isolated pelvis perfusion | Drug | — | UNRESOLVED |
| radiotherapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy
- description
- Isolated pelvis perfusion
- interventionNames
- Drug: Isolated pelvis perfusion
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Standard treatment
- interventionNames
- Radiation: radiotherapy
- Procedure: Surgery
Primary outcomes (1)
- measure
- Survival rate
- timeFrame
- From randomization to death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 76 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.