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Curative Efficacy of Pravastatine in Patients Presented Delayed Cutaneous and Subcutaneous Radio-induced Fibrosis


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Fibrosis

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Trial Information

Curative Efficacy of Pravastatine in Patients Presented Delayed Cutaneous and Subcutaneous Radio-induced Fibrosis


Inclusion Criteria:



1. Grade >= 2 cutaneous and/or subcutaneous fibrosis (NCI-CTCAE v4 toxicities scale)
revealed from 6 to 24 months after head and neck radiotherapy.

2. Head and neck cancers treated by radiation therapy +/- chemotherapy, +/- surgery,
with no evidence of progressive disease.

3. Age >= 18

4. Karnofsky PS ≥ 70

5. normal renal function (plasmatic creatinine <= 130 micromol/l), normal cholesterol,
normal hepatic function (total bilirubin <= 1.5 UNL, SGOT and SGPT <= 2 UNL)

6. Written informed consent of the patient.

Exclusion Criteria:

1. any chronic treatment by corticoids

2. severe cardiac pathology

3. patients already treated by statins or treated by fibrates, cyclosporine

4. history of muscular toxicities when treated by fibrates or by statins

5. Personal or familial history of hereditary muscular pathology

6. Plasmatic CPK >3 UNL

7. patient already included in another therapeutic trial with an experimental drug,

8. pregnant patient or susceptible to pregnancy or breast feeding (patients in age to
give birth must be placed under efficient contraception),

9. a social or psychological condition that does not allow a positive patient's
participation in the treatment and necessary medical follow-up to be envisaged,

10. the patient is under legal restrained or tutelage.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

regression of radio-induced fibrosis (RIF) evaluated by high frequency ultrasound

Outcome Description:

a decrease of the maximal thickness more than 30% compared to RIF before treatment.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Céline BOURGIER, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CSET 1383 - PRAVACUR

NCT ID:

NCT01268202

Start Date:

December 2010

Completion Date:

June 2013

Related Keywords:

  • Fibrosis
  • cutaneous radioinduced fibrosis
  • Fibrosis

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