Trial Information
Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal
Inclusion Criteria:
- ECOG performance status ≤ 1
- patient with metastatic anal cancer HPV+
- presence of a measurable target lesion according to radiological criteria (Recist
V1.1)
- patient with more than 12 months of complete remission of metastatic anal cancer
according to radiological criteria (Recist V1.1)after treatment by DCF regimen
(Docetaxel, Cisplatin and 5-Fluorouracil)
Exclusion Criteria:
- pregnancy or lactation
- patient with any medical or psychiatric condition or disease which would make the
patient inappropriate for entry into this study.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
presence and characterization of anti-HPV immune responses in patients in complete remission
Outcome Time Frame:
3 months after sample
Safety Issue:
No
Authority:
France: Committee for the Protection of Person
Study ID:
Epitope-HPV01
NCT ID:
NCT01845779
Start Date:
September 2012
Completion Date:
September 2015
Related Keywords:
- Metastatic Anal Canal Cancer
- Human Papillomavirus
- Neoplasm Metastasis
- Anus Neoplasms