Study About Preventive Treatment of Folliculitis Induced by Epidermal Growth Factor Receptor Inhibitors
DIPROCOL
Phase II Multicentric Study About Preventive Treatment of Folliculitis Induced by the EGF-R Inhibitors in Patients With Metastatic Colorectal Cancer and Treated by Cetuximab or With Non-small-cell Lung Carcinoma Treated by Erlotinib
1 other identifier
interventional
30
1 country
3
Brief Summary
Patients will receive local prophylactic treatment (Diprosone cream) during 8 weeks from the beginning of the EGF-R inhibitors treatment, on the areas of the body susceptible to be affected by folliculitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2007
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 1, 2009
CompletedJuly 31, 2012
July 1, 2012
1.4 years
May 29, 2009
July 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To reduce by 30 % the frequency of folliculitis by a local corticotherapy beginning at the same time that the treatment by EGF-R inhibitors began
2 months of treatment by corticotherapy
Secondary Outcomes (3)
To assess the frequency of grade I, II and III folliculitis under Cetuximab and under Erlotinib
2 months of treatment
To list the cutaneous side effects of the EGF-R inhibitors
2 months of treatment
To assess the patient quality of life with the DLQI questionnaire
2 months of treatment
Study Arms (1)
DIPROSONE
EXPERIMENTALInterventions
* Start of treatment: as soon as the EGF-R inhibitors treatment begins * Application: On the body area susceptible to be affected by folliculitis, once a day, in the evening * Dosage: Quantity corresponded to around 2 tubes of 30 grams a week on the face, the chest and upper side of the back. There is no maximum dosage. * Period of treatment: 8 weeks
Eligibility Criteria
You may qualify if:
- Indication of Cetuximab in patients with metastatic colorectal cancer in association or not with irinotecan, after failure of a chemotherapy treatment with Irinotecan OR
- Indication of Erlotinib, in patients with metastatic Non-Small-Cell Lung Carcinoma, after failure of at least one chemotherapy treatment
- No pre-existing cutaneous toxicity
You may not qualify if:
- Contraindication to local corticotherapy
- Previous history of severe hypersensibility reactions (Grade III or IV) due to Cetuximab, Irinotecan or Erlotinib
- Betamethasone or one of excipient product allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Oscar Lambretlead
- Roche Pharma AGcollaborator
Study Sites (3)
Centre Oscar Lambret
Lille, 59020, France
Centre Hospitalier Regional
Lille, 59035, France
Centre Hospitalier Régional
Lille, 59035, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent MORTIER, MD
Centre Hospitalier Régional et Universitaire de LILLE
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2009
First Posted
June 1, 2009
Study Start
October 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
July 31, 2012
Record last verified: 2012-07