Last reviewed · How we verify
NCT00949039
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
Phase 3 trial testing Isolated pelvis perfusion in Gynaecologic or Digestive Pelvic Cancer in 101 participants. Completed in 1 March 2014.
1 March 2014
Quick facts
| Lead sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 101 |
| Start date | 1 February 2009 |
| Primary completion | 1 March 2014 |
| Estimated completion | 1 March 2014 |
| Sites | 1 location across France |
Drugs / interventions tested
- Isolated pelvis perfusion — full drug profile →
- radiotherapy — full drug profile →
- Surgery
Conditions studied
- Gynaecologic or Digestive Pelvic Cancer — all drugs for Gynaecologic or Digestive Pelvic Cancer →
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris — full company profile →
Who can join
Adults 18 to 76, any sex, with Gynaecologic or Digestive Pelvic Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Survival rate
Time frame: From randomization to death
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00949039
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00949039 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gustave Roussy, Cancer Campus, Grand Paris
- Last refreshed: 11 March 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00949039.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing