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NCT01268202: PRAVACUR
Curative Efficacy of Pravastatine in Patients Presented Delayed Cutaneous and Subcutaneous Radio-induced Fibrosis
Phase 2 trial testing Pravastatin in Fibrosis in 61 participants. Completed in 18 April 2019.
18 April 2019
Quick facts
| Lead sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 61 |
| Start date | 17 December 2010 |
| Primary completion | 18 April 2019 |
| Estimated completion | 18 April 2019 |
| Sites | 3 locations across France |
Drugs / interventions tested
- Pravastatin — full drug profile →
Conditions studied
- Fibrosis — all drugs for Fibrosis →
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris — full company profile →
Who can join
18 and older, any sex, with Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Molecular mechanisms involved in radio-induced fibrosis are assessed in UPRES EA 27-10 since 10 years. Besides the canonical TGFbeta/ Smad pathway involved in radio-induced fibrosis (RIF), the Rho/ROCK/CTGF cascade has been shown to be also implicated in molecular mechanisms of RIF. Curative administration of Pravastatin or ROCK specific inhibitors inhibits the chronically activated Rho/ROCK/CTGF pathway in vitro in human cells lines and ex vivo in human samples. In addition, the curative administration of Pravastatin improves established RIF in vivo. The investigators data suggest that the pravastatin-based strategy is an efficient and safe antifibrotic therapy, easily transferable into the clinic to improve the quality of life of long-term cancer survivors without interfering with prior anticancer treatment. This clinical trial evaluates the curative efficacy of Pravastatine in patients who presented a cutaneous and/ or subcutaneous fibrosis (grade \>= 2 according to NCI-CTCAE v4 toxicities scale) and who were treated by radiotherapy for a head and neck cancer. Patients will be treated by Pravastatin during 12 months. An intermediate evaluation of efficacy by ultrasound will be assessed at 6 months and at last, at the end of the treatment. Patients assessment will be performed at 6 and 12 months after the end of the treatment to look at a potential rebound effect. Objective(s) of the clinical study Main objective: To assess Pravastatin efficacy in established cutaneous and subcutaneous radio-induced fibrosis revealed from 6 to 24 months after head and neck radiotherapy. Second objective: To evaluate radio-induced fibrosis regression during the year following treatment stop.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Role of Myofibroblasts in Physiological and Pathological Tissue Repair.
Schuster R, Younesi F, Ezzo M, Hinz B. · · 2023 · cited 148× · PMID 36123034 · DOI 10.1101/cshperspect.a041231 -
Multifunctional regulatory protein connective tissue growth factor (CTGF): A potential therapeutic target for diverse diseases.
Fu M, Peng D, Lan T, Wei Y, et al · · 2022 · cited 55× · PMID 35847511 · DOI 10.1016/j.apsb.2022.01.007 -
Pravastatin Reverses Established Radiation-Induced Cutaneous and Subcutaneous Fibrosis in Patients With Head and Neck Cancer: Results of the Biology-Driven Phase 2 Clinical Trial Pravacur.
Bourgier C, Auperin A, Rivera S, Boisselier P, et al · · 2019 · cited 39× · PMID 30776452 · DOI 10.1016/j.ijrobp.2019.02.024 -
Matricellular proteins in drug delivery: Therapeutic targets, active agents, and therapeutic localization.
Sawyer AJ, Kyriakides TR. · · 2016 · cited 38× · PMID 26763408 · DOI 10.1016/j.addr.2015.12.016 -
Modelling and targeting mechanical forces in organ fibrosis.
Mascharak S, Guo JL, Griffin M, Berry CE, et al · · 2024 · cited 23× · PMID 39552705 · DOI 10.1038/s44222-023-00144-3 -
Immunometabolism changes in fibrosis: from mechanisms to therapeutic strategies.
Feng L, Chen X, Huang Y, Zhang X, et al · · 2023 · cited 17× · PMID 37576819 · DOI 10.3389/fphar.2023.1243675 -
Connective Tissue Growth Factor: Regulation, Diseases, and Drug Discovery.
Ren M, Yao S, Chen T, Luo H, et al · · 2024 · cited 10× · PMID 38731911 · DOI 10.3390/ijms25094692 -
Radiomitigators: Breakthroughs in Post-Radiation Recovery.
Obrador E, Estrela JM, López-Blanch R, Moreno-Murciano P, et al · · 2026 · PMID 41897526 · DOI 10.3390/antiox15030381
Verify or expand the search:
- PubMed search for NCT01268202
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Other recruiting trials for Fibrosis
Currently open trials in the same condition.
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Other Gustave Roussy, Cancer Campus, Grand Paris trials
Trials by the same sponsor.
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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 NCT01268202 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 13 June 2019
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/NCT01268202.
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