Human Papillomavirus, Metastatic Anal Canal Cancer
Conditions
Brief summary
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.
Interventions
DRUGDCF regimen
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| presence and characterization of anti-HPV immune responses in patients in complete remission | 3 months after sample |
Secondary
| Measure | Time frame |
|---|---|
| global survival | from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months |
| progression free survival | from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months |
Countries
France
Outcome results
None listed