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出境医 / 临床实验 / Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates (BOOST-CA)
Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates (BOOST-CA)
Study Description
Brief Summary:
Comparative retrospective study of two anal canal brachytherapy techniques aimed at boosting [low dose rate (LDR) and high dose rate (HDR)]
| Condition or disease | Intervention/treatment |
|---|---|
| Anal Canal Cancer | Radiation: Brachytherapy |
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
| Study Type : | Observational |
| Actual Enrollment : | 89 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| Official Title: | Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates |
| Actual Study Start Date : | August 17, 2007 |
| Actual Primary Completion Date : | July 28, 2016 |
| Actual Study Completion Date : | July 28, 2016 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Low Dose Rate
Patients treated with brachytherapy at low dose rate of the anal canal with aim of boost
|
Radiation: Brachytherapy
Brachytherapy
|
|
High Dose Rate
Patients treated by brachytherapy with a high dose rate of the anal canal aiming for boost
|
Radiation: Brachytherapy
Brachytherapy
|
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Estimation of local control [ Time Frame: 1 year ]Local control defined as the time between the date of diagnosis and the date of local relapse or death or recent news
- Estimation of disease free survival [ Time Frame: 1 year ]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
- Estimation of overall survival [ Time Frame: 1 year ]Overall survival defined as the time between the date of diagnosis and the date of death or latest news
- Comparison of the incidence of toxicities (CTCAE v4) between the 2 groups [ Time Frame: 1 year ]rate of toxicities
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients treated with anal canal brachytherapy for boost, between 2008 and 2016.
Criteria
Inclusion Criteria:
- Patients treated by brachytherapy anal canal to boost.
Exclusion Criteria:
- Patients below age of 18 years
Contacts and Locations
Locations
| France | |
| Institut Paoli Calmettes | |
| Marseille, Bouches Du Rhone, France, 13009 | |
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
| Principal Investigator: | Leonel VARELA GAGETTI | Institut Paoli-Calmettes |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | March 5, 2018 | ||||
| First Posted Date | March 14, 2018 | ||||
| Last Update Posted Date | March 14, 2018 | ||||
| Actual Study Start Date | August 17, 2007 | ||||
| Actual Primary Completion Date | July 28, 2016 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates | ||||
| Official Title | Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates | ||||
| Brief Summary | 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 Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients treated with anal canal brachytherapy for boost, between 2008 and 2016. | ||||
| Condition | Anal Canal Cancer | ||||
| Intervention | Radiation: Brachytherapy
Brachytherapy
|
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| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
89 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | July 28, 2016 | ||||
| Actual Primary Completion Date | July 28, 2016 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03465501 | ||||
| Other Study ID Numbers | BOOST-CA IPC 2017-016 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Institut Paoli-Calmettes | ||||
| Study Sponsor | Institut Paoli-Calmettes | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Institut Paoli-Calmettes | ||||
| Verification Date | March 2018 | ||||
