Curative Efficacy of Pravastatine in Patients Presented Delayed Cutaneous and Subcutaneous Radio-induced Fibrosis (PRAVACUR)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Curative Efficacy of Pravastatine in Patients Presented Delayed Cutaneous and Subcutaneous Radio-induced Fibrosis|
- regression of radio-induced fibrosis (RIF) evaluated by high frequency ultrasound [ Time Frame: 12 months ] [ Designated as safety issue: No ]a decrease of the maximal thickness more than 30% compared to RIF before treatment.
- Fibrosis grade according to NCI-CTCAE v4 toxicities scale. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]VQ-Dermato scale
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Pravastatin : 40mg/day during 12 months
Pravastatin 40mg/day during 12 months
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268202
|Contact: Sofia Rivera, MDfirstname.lastname@example.org|
|Contact: Aurélie Abou Lovergneemail@example.com|
|Centre Val d'Aurelle||Not yet recruiting|
|Montpellier, France, 34298|
|Contact: David AZRIA, MD|
|Principal Investigator: David AZRIA, MD|
|Hôpital Européen Georges Pompidou||Not yet recruiting|
|Paris, France, 75015|
|Contact: Philippe GIRAUD, MD|
|Principal Investigator: Philippe GIRAUD, MD|
|Institut Gustave Roussy||Recruiting|
|Villejuif, France, 94805|
|Contact: Céline BOURGIER, MD, PhD 33 1 42 11 49 31 firstname.lastname@example.org|
|Contact: Anne AUPERIN, MD, PhD 33 1 42 11 54 99 email@example.com|
|Principal Investigator: Céline BOURGIER, MD, PhD|
|Study Chair:||Sofia Rivera, MD||Gustave Roussy, Cancer Campus, Grand Paris|