Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal (Epitopes-HPV01)
Complete response is a rare event in metastatic anal cancer in the case of unresectable recurrence after radiochemotherapy.
In the University Hospital Center of Besançon, 8 patients with metastatic anal cancer were treated between 2005 and 2008 by 6 cycles of chemotherapy including taxane: DCF (Docetaxel, Cisplatin and 5-Fluorouracil.
In more than 90% of cases, anal cancers are related to Human Papilloma Virus (HPV) infection, that is the case of this patients for which HPV16 (human papillomavirus type 16) genotype was identified within the tumor samples.
The hypothesis is that an anti-HPV response immune could be generated by chemotherapy with DCF and contributed to the elimination of the tumour cells and to the increase of complete responses. The aim to this study is to analyze immune response against HPV in this patients in complete response.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal|
- presence and characterization of anti-HPV immune responses in patients in complete remission [ Time Frame: 3 months after sample ] [ Designated as safety issue: No ]
- global survival [ Time Frame: from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months ] [ Designated as safety issue: No ]
- progression free survival [ Time Frame: from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||January 2020|
|Estimated Primary Completion Date:||January 2020 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01845779
|Contact: Christophe BORG, Profemail@example.com|
|Contact: Marion JACQUINfirstname.lastname@example.org|
|Medical Oncology - University Hospital of Besançon||Recruiting|
|Besançon, France, 25000|
|Contact: Christophe BORG, Prof +3381615615 email@example.com|
|Contact: Marion JACQUIN firstname.lastname@example.org|
|Principal Investigator: Christophe BORG, Prof|
|Sub-Investigator: Jean-François BOSSET, Prof|
|Sub-Investigator: Thierry Nguyen, Doctor|