Clinical Trial Results:
Phase II randomized trial comparating two concomitant administration of radiotherapy with cisplatin in patients with not operated or inoperable squamous cell carcinoma of the head and neck or with recurrence high-risk in adjuvant postoperative treatment.
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Summary
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EudraCT number |
2015-001928-29 |
Trial protocol |
FR |
Global end of trial date |
10 May 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Apr 2024
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First version publication date |
07 Apr 2024
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Other versions |
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Summary report(s) |
Summary |
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 |
GORTEC 2015-02: CisFRad
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03330249 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GORTEC
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Sponsor organisation address |
4 Bis Rue Emile Zola, TOURS, France, 37000
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Public contact |
Adeline PECHERY, GORTEC, 33 (0)6 49 21 06 07, adeline.pechery@gortec.fr
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Scientific contact |
Dr Lionnel GEOFFROIS, GORTEC, 33 (0)3 68 76 67 67, c.borel@icans.eu
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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 |
04 Oct 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 May 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
10 May 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 |
Compare the cumulative dose of Cisplatin administered concomitantly with radiotherapy in the reference arm A (Cisplatin 100 mg / m2 J1 every 21 days) and in the experimental B arm (Split Cisplatin 25 mg / m2 / D D1 to D4 every 21 days).
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Protection of trial subjects |
Follow-up of patients according to the protocol calendar, adaptation of treatment or discontinuation of
treatment according to toxicities
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Dec 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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: 124
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Worldwide total number of subjects |
124
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EEA total number of subjects |
124
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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) |
88
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From 65 to 84 years |
36
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85 years and over |
0
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Recruitment
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Recruitment details |
The study is presented to patients during a standard visit by the investigator. If the patient agrees to participate and meets the eligibility criteria, then they can be included in the trial. | ||||||||||||||||||
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Pre-assignment
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Screening details |
-Squamous cell carcinoma of the upper aerodigestive tract, stage III or IV - Patient not operated on and/or not operable for reasons of non-extirpability, loco-regional extension, general state or medical condition Or Patient operated on within 8 weeks preceding radiotherapy with a high risk of recurrence | ||||||||||||||||||
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Period 1
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Period 1 title |
final analysis (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 | ||||||||||||||||||
Arm description |
Standard arm | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
CISPLATINE
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Cisplatine : 100 mg/m2 in IV at D1, D22 and D43 of the radiotherapy
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Arm title
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Arm B | ||||||||||||||||||
Arm description |
Fractionned experimental | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
CISPLATINE
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Cisplatine : 25 mg/m2/d in IV at D1 à J4, D22 to D25 and D43 to D46 of the radiotherapy
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Baseline characteristics reporting groups
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Reporting group title |
Arm A
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Reporting group description |
Standard arm | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Arm B
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Reporting group description |
Fractionned experimental | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Arm A
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Reporting group description |
Standard arm | ||
Reporting group title |
Arm B
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Reporting group description |
Fractionned experimental | ||
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End point title |
Cumulative dose of Cisplatin administered in the intention to treat [1] | ||||||||||||
End point description |
Cumulative dose of cisplatin delivered during radiotherapy compared between the two arms
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End point type |
Primary
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End point timeframe |
At the end of study
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: See in the summary of report |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Cumulative dose of Cisplatin administered in the per-protocol [2] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At the end of study
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: See in the summary of report |
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
monitoring of tolerance begins when the subject is included in the study (date of signing the informed consent) until the completion of the end-of-study visit.
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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 |
16.0
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Reporting groups
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Reporting group title |
Arm A
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Arm B
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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25 Nov 2015 |
- Clarification of the examinations to be carried out during post-treatment follow-up
- Analysis of HPV status for patients with an oropharynx tumor
- Development of the research hypothesis, following the question asked by the EC during the initial submission |
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19 Feb 2016 |
-Clarification of the examinations to be carried out: certain examinations present in the body of the protocol have been forgotten in the table of investigations;
- Modification of the duration of follow-up of the study due to topography error: In the synopsis, it is noted that the follow-up is up to one year while in the table of investigations, it is up to 3 years;
- Urine samples are made optional;
- Pharmacokinetics (PK) is also made optional because it requires a lot of involvement from the center. On the other hand, if the center decides to do it, it will only be carried out during the first cycle of treatment. |
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07 Jun 2016 |
Updated list of centers |
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13 Sep 2016 |
Updated list of centers |
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02 Feb 2017 |
Updated list of centers |
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10 Oct 2017 |
Increase in the number of patients to be included |
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15 May 2018 |
Extension of the inclusion period and updating of the list of centers |
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07 Jul 2020 |
Updated list of centers |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
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 | |||
