Description:
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.
Title
- Brief Title: Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal
- Official Title: Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal
Clinical Trial IDs
- ORG STUDY ID:
Epitope-HPV01
- NCT ID:
NCT01845779
Conditions
- Metastatic Anal Canal Cancer
- Human Papillomavirus
Interventions
| Drug | Synonyms | Arms |
|---|
| DCF regimen | | patients in complete response |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| patients in complete response | Experimental | | |
Eligibility Criteria
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | presence and characterization of anti-HPV immune responses in patients in complete remission |
| Time Frame: | 3 months after sample |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | global survival |
| Time Frame: | from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months |
| Safety Issue: | |
| Description: | |
| Measure: | progression free survival |
| Time Frame: | from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months |
| Safety Issue: | |
| Description: | |
Details
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Centre Hospitalier Universitaire de Besancon |
Last Updated
May 20, 2020
