Metastatic Anal Canal CancerEpitopes-HPV01NCT01845779
Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal
A study testing DCF regimen in people with Metastatic Anal Canal Cancer and Human Papillomavirus, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Anal Canal Cancer, Human Papillomavirus
- What is being tested?
- DCF regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- pregnancy or lactation
- patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
France1 site
Medical Oncology - University Hospital of Besançon
Besançon, 25000
About this study
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.
Read more
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.
- Conditions
- Metastatic Anal Canal Cancer, Human Papillomavirus
- Being tested
- DCF regimen
- Medical subject headings
- Anal Canal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCF regimenDrug
| Study group | Role | What they receive |
|---|---|---|
| patients in complete response | Experimental | Not described Receives: Drug: DCF regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence and characterization of anti-HPV immune responses in patients in complete remission
Measured: 3 months after sample
Secondary outcomes (2)
global survival
Measured: from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months
progression free survival
Measured: from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startSep 2012
- Primary completionJul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Anal Canal CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845779
- Sponsor's protocol ID
- Epitope-HPV01
- Acronym
- Epitopes-HPV01
- Status last verified
- May 2020
- First submitted
- 15 Apr 2013
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal
- ClinicalTrials.gov ID
- NCT01845779
- Acronym / sponsor ID
- Epitopes-HPV01 / Epitope-HPV01
- Conditions
- Metastatic Anal Canal Cancer, Human Papillomavirus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients in complete response | Experimental | Drug: DCF regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- pregnancy or lactation
- patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCF regimen | Drug | patients in complete response |
Primary outcome
presence and characterization of anti-HPV immune responses in patients in complete remission
Time frame: 3 months after sample
2 secondary outcomes
global survival
Time frame: from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months
progression free survival
Time frame: from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCF regimen in people with Metastatic Anal Canal Cancer and Human Papillomavirus, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence and characterization of anti-HPV immune responses in patients in complete remission (time frame: 3 months after sample). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.