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CompletedNCT01845779Epitopes-HPV01Updated May 20, 2020

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

An interventional study of DCF regimen in Metastatic Anal Canal Cancer and Human Papillomavirus, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-20.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Sep 2012, registered Apr 2013).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Metastatic Anal Canal Cancer
  • Human Papillomavirus

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03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 64 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    patients in complete response

    Drug: DCF regimen

Interventions

  • DrugDCF regimen
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What researchers measure

Primary outcomes

  1. presence and characterization of anti-HPV immune responses in patients in complete remission

    Time frame: 3 months after sample

Secondary outcomes

  1. global survival

    Time frame: from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months

  2. progression free survival

    Time frame: from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months

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Study locations

1 site
  • Medical Oncology - University Hospital of Besançon
    Besançon, 25000, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01845779
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
May 3, 2013
Start date
Sep 2012
Primary completion
Jul 2019
Completion
Dec 31, 2019
Last update
May 20, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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