Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal

Not Applicable

Completed

• Conditions: Metastatic Anal Canal Cancer; Human Papillomavirus
• Interventions: Drug: DCF regimen

• Registration Number: NCT01845779
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-05-02
• Study First Posted: 2013-05-03
• Primary Completion: 2019-07
• Study Completion: 2019-12-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients in complete response	DCF regimen	-

Primary Outcome Measures

Name	Time	Method
presence and characterization of anti-HPV immune responses in patients in complete remission	3 months after sample

Secondary Outcome Measures

Name	Time	Method
progression free survival	from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months
global survival	from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months

Trial Locations

Locations (1)

Medical Oncology - University Hospital of Besançon; 🇫🇷 Besançon, France