Clinical Trial Results:
CICA-RT – Phase III randomized multicenter study evaluating Cicaderma® ointment efficacy versus the current practice of each center for the radiation dermatitis prevention in patients with non-metastatic breast cancer after adjuvant post-operative breast irradiation
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Summary
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EudraCT number |
2019-001711-23 |
Trial protocol |
FR |
Global end of trial date |
01 Jul 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Nov 2022
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First version publication date |
06 Nov 2022
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Other versions |
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Summary report(s) |
RRF |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ET19-084
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Centre Léon Bérard
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Sponsor organisation address |
28 rue Laennec, Lyon Cedex 08, France, 69373
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Public contact |
Séverine METZGER, Centre Léon Bérard, +33 4 78 78 28 28,
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Scientific contact |
Dr Séverine RACADOT
Pr Youlia KIROVA, Centre Léon Bérard, +33 4 78 78 28 28,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
05 Nov 2021
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jul 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To compare the efficacy of Cicaderma® ointment versus the standard care of each center in the prevention of grade > 2 radiation dermatitis according to National Cancer Institute – Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)
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Protection of trial subjects |
The investigator proceeded to the following information/procedures during the screening visit:
- Fully inform the patient of the study treatments, the objectives and the design of the study, answer to any questions that the patient may have and ensure that the patient understands the potential risks and benefits of participating in the study before signing the informed consent form. None study-related procedure can be started before ICF is signed and dated by both the patient (and impartial witness, if applicable).
- Check the eligibility criteria list and perform the exams.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Jun 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 258
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Worldwide total number of subjects |
258
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EEA total number of subjects |
258
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
148
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From 65 to 84 years |
80
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85 years and over |
30
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Recruitment
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Recruitment details |
Patients were recruited at the time of enrolment at the participating sites. The declared investigator, after having identified a potential candidate for the study, informed her orally of the terms of the study and provide her with : an information note, An informed consent form that has been dated and signed by the patient and the investigator. | |||||||||
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Pre-assignment
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Screening details |
None study-related procedure can be started before ICF was signed and dated by both the patient (and impartial witness, if applicable) and the investigator - Checked the eligibility criteria list and perform the exams. | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Arm A: Hygiene rules and preventive treatment with Cicaderma® | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Cicaderma®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Route of administration not applicable
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Dosage and administration details |
2 applications per day for 30 days
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Arm title
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Arm B: Standard Pratice | |||||||||
Arm description |
- | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Arm A: Hygiene rules and preventive treatment with Cicaderma®
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Reporting group description |
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Reporting group title |
Arm B: Standard Pratice
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Primary endpoint in Cicaderma arm
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Intention-to-treat (ITT) population: defined as all patients randomised, regardless of treatment received and study conduct. Patients will be analysed according to their initial randomisation group, regardless of the actual treatment received.
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Subject analysis set title |
Primary endpoint in standard practice arm
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Intention-to-treat (ITT) population: defined as all patients randomised, regardless of treatment received and study conduct. Patients will be analysed according to their initial randomisation group, regardless of the actual treatment received.
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End points reporting groups
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Reporting group title |
Arm A: Hygiene rules and preventive treatment with Cicaderma®
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Reporting group description |
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Reporting group title |
Arm B: Standard Pratice
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Reporting group description |
- | ||
Subject analysis set title |
Primary endpoint in Cicaderma arm
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Intention-to-treat (ITT) population: defined as all patients randomised, regardless of treatment received and study conduct. Patients will be analysed according to their initial randomisation group, regardless of the actual treatment received.
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Subject analysis set title |
Primary endpoint in standard practice arm
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Intention-to-treat (ITT) population: defined as all patients randomised, regardless of treatment received and study conduct. Patients will be analysed according to their initial randomisation group, regardless of the actual treatment received.
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End point title |
Efficacy Primary endpoint | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
30 days
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Statistical analysis title |
Efficacy Primary endpoint | |||||||||||||||
Comparison groups |
Arm B: Standard Pratice v Arm A: Hygiene rules and preventive treatment with Cicaderma®
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Number of subjects included in analysis |
258
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Analysis specification |
Post-hoc
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Analysis type |
equivalence | |||||||||||||||
P-value |
= 1 | |||||||||||||||
Method |
Chi-squared | |||||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
The investigator collects (spontaneous patient report or questionning) and immediately notifies the sponsor of all SAEs, in a written report, wether or not theay are deemed to be attributable to research and wich occur during the study.
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
21.0
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Non-serious events were collected and not specifically reported. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
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02 Jun 2020 |
- Implementation of an urgent safety measure following COVID-19. A letter dated 27 May 2020 mentioning this notification was sent to the authorities on 28 May 2020. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
| None reported | |||||||
