Anal Canal CancerBOOST-CANCT03465501
Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates
An observational study of Anal Canal Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
Comparative retrospective study of two anal canal brachytherapy techniques aimed at boosting [low dose rate (LDR) and high dose rate (HDR)] Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Canal Cancer
- What is being tested?
- Brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 17 Aug 2007to 28 Jul 2016
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients treated with anal canal brachytherapy for boost, between 2008 and 2016.
Who may be able to join
- Patients treated by brachytherapy anal canal to boost.
Who cannot join
- Patients below age of 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Comparative retrospective study of two anal canal brachytherapy techniques aimed at boosting [low dose rate (LDR) and high dose rate (HDR)]
Read the detailed description
Efficacy of anal canal interstitial brachytherapy evaluated by local relapse rate, Tolerance of interstitial brachytherapy of the anal canal evaluated by the rate of chronic toxicities.
- Conditions
- Anal Canal Cancer
- Being tested
- Brachytherapy
- Keywords
- Anal Canal Cancer, brachytherapy
- 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.
BrachytherapyRadiation
Brachytherapy
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Rate | Patients treated with brachytherapy at low dose rate of the anal canal with aim of boost Receives: Radiation: Brachytherapy | |
| High Dose Rate | Patients treated by brachytherapy with a high dose rate of the anal canal aiming for boost Receives: Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of interstitial brachytherapy of the anal canal
Efficacy of anal canal interstitial brachytherapy evaluated by local relapse rate
Measured: 1 year
Evaluation of the tolerance of interstitial brachytherapy of the anal canal
Tolerance of interstitial brachytherapy of the anal canal evaluated by the rate of chronic toxicities.
Measured: 1 year
Secondary outcomes (4)
Estimation of local control
Local control defined as the time between the date of diagnosis and the date of local relapse or death or recent news
Measured: 1 year
Estimation of disease free survival
Disease free survival defined as the delay between the date of diagnosis and the date of local or locoregional or distant relapse or death or recent news
Measured: 1 year
Estimation of overall survival
Overall survival defined as the time between the date of diagnosis and the date of death or latest news
Measured: 1 year
Comparison of the incidence of toxicities (CTCAE v4) between the 2 groups
rate of toxicities
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start17 Aug 2007
- Primary completion28 Jul 2016
- Study completion28 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anal Canal CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonel VARELA GAGETTI, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465501
- Sponsor's protocol ID
- BOOST-CA IPC 2017-016
- Acronym
- BOOST-CA
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cordoba A, Escande A, Leroy T, Mirabel X, Coche-Dequeant B, Lartigau E. Low-dose-rate interstitial brachytherapy boost for the treatment of anal canal cancers. Brachytherapy. 2017 Jan-Feb;16(1):230-235. doi: 10.1016/j.brachy.2016.07.007. Epub 2016 Sep 3.
PubMed 27600606Boukhelif W, Ferri-Molina M, Mazeron R, Maroun P, Duhamel-Oberlander AS, Dumas I, Martinetti F, Guemnie-Tafo A, Chargari C, Haie-Meder C. Interstitial pulsed-dose-rate brachytherapy for the treatment of squamous cell anal carcinoma: A retrospective single institution analysis. Brachytherapy. 2015 Jul-Aug;14(4):549-53. doi: 10.1016/j.brachy.2015.03.006. Epub 2015 Apr 29.
PubMed 25935731
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates
- ClinicalTrials.gov ID
- NCT03465501
- Acronym / sponsor ID
- BOOST-CA / BOOST-CA IPC 2017-016
- Conditions
- Anal Canal Cancer
- Keywords
- Anal Canal Cancer, brachytherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 17 Aug 2007 (actual)
- Primary completion
- 28 Jul 2016 (actual)
- Study completion
- 28 Jul 2016 (actual)
- First posted
- 14 Mar 2018 (actual)
- 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.
Comparative retrospective study of two anal canal brachytherapy techniques aimed at boosting [low dose rate (LDR) and high dose rate (HDR)]
Detailed description
Efficacy of anal canal interstitial brachytherapy evaluated by local relapse rate, Tolerance of interstitial brachytherapy of the anal canal evaluated by the rate of chronic toxicities.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose Rate | – | Radiation: BrachytherapyPatients treated with brachytherapy at low dose rate of the anal canal with aim of boost |
| High Dose Rate | – | Radiation: BrachytherapyPatients treated by brachytherapy with a high dose rate of the anal canal aiming for boost |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients treated with anal canal brachytherapy for boost, between 2008 and 2016.
Key inclusion criteria (1 listed)
- Patients treated by brachytherapy anal canal to boost.
Key exclusion criteria (1 listed)
- Patients below age of 18 years
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 |
|---|---|---|
| BrachytherapyBrachytherapy | Radiation | High Dose Rate, Low Dose Rate |
Primary outcome
Evaluation of the efficacy of interstitial brachytherapy of the anal canal
Time frame: 1 year
Efficacy of anal canal interstitial brachytherapy evaluated by local relapse rate
Evaluation of the tolerance of interstitial brachytherapy of the anal canal
Time frame: 1 year
Tolerance of interstitial brachytherapy of the anal canal evaluated by the rate of chronic toxicities.
4 secondary outcomes
Estimation of local control
Time frame: 1 year
Estimation of disease free survival
Time frame: 1 year
Estimation of overall survival
Time frame: 1 year
Comparison of the incidence of toxicities (CTCAE v4) between the 2 groups
Time frame: 1 year
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 14 Mar 2018.
- Results publication: PubMed 27600606Cordoba A, Escande A, Leroy T, Mirabel X, Coche-Dequeant B, Lartigau E. Low-dose-rate interstitial brachytherapy boost for the treatment of anal canal cancers. Brachytherapy. 2017 Jan-Feb;16(1):230-235. doi: 10.1016/j.brachy.2016.07.007. Epub 2016 Sep 3.
- Results publication: PubMed 25935731Boukhelif W, Ferri-Molina M, Mazeron R, Maroun P, Duhamel-Oberlander AS, Dumas I, Martinetti F, Guemnie-Tafo A, Chargari C, Haie-Meder C. Interstitial pulsed-dose-rate brachytherapy for the treatment of squamous cell anal carcinoma: A retrospective single institution analysis. Brachytherapy. 2015 Jul-Aug;14(4):549-53. doi: 10.1016/j.brachy.2015.03.006. Epub 2015 Apr 29.
- Individual participant dataSharing planned: No
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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.
Leonel VARELA GAGETTI principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Canal Cancer, run by Institut Paoli-Calmettes 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 1 inclusion and 1 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 14 Mar 2018. 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?
Evaluation of the efficacy of interstitial brachytherapy of the anal canal (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03465501, which also lists 2 linked publications.
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 14 Mar 2018.