Trial Outcomes & Findings for Definition for the Assessment of Time-to-event Endpoints in CANcer Trials (DATECAN-1) (NCT NCT03676010)
NCT ID: NCT03676010
Last Updated: 2025-12-10
Results Overview
Number of time-to-event outcomes defined following the consensus process
Recruitment status
ACTIVE_NOT_RECRUITING
Target enrollment
265 participants
Primary outcome timeframe
1 year after the consitution of the panel of experts
Results posted on
2025-12-10
Participant Flow
Participant milestones
| Measure |
Sarcoma and GIST
Sarcoma and GIST: No Intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
Breast Cancer
Breast cancer: No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
Pancreatic Cancer
Pancreatic cancer: No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
Renal Cell Carcinoma
Renal cell carcinoma: No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
Colon Cancer (Adjuvant Setting)
Colon cancer: No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy (adjuvant setting).
|
Solid Tumours Undergoing Image-guided Tumor Ablation
No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
(Early) Non Small Cell Lung Cancer
No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
35
|
33
|
36
|
24
|
36
|
69
|
|
Overall Study
COMPLETED
|
28
|
31
|
30
|
31
|
24
|
24
|
54
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
3
|
5
|
0
|
12
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sarcoma and GIST
n=28 Participants
Sarcoma and GIST: No Intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
Breast Cancer
n=31 Participants
Breast cancer: No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
Pancreatic Cancer
n=30 Participants
Pancreatic cancer: No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
Renal Cell Carcinoma
n=31 Participants
Renal cell carcinoma: No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
Colon Cancer (Adjuvant Setting)
n=24 Participants
Colon cancer: No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy (adjuvant setting).
|
Solid Tumours Undergoing Image-guided Tumor Ablation
n=24 Participants
No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
(Early) Non Small Cell Lung Cancer
n=54 Participants
No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18 years and older
|
28 Participants
n=28 Participants
|
31 Participants
n=31 Participants
|
30 Participants
n=30 Participants
|
31 Participants
n=31 Participants
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
54 Participants
n=54 Participants
|
222 Participants
n=222 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=28 Participants
|
11 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
11 Participants
n=31 Participants
|
7 Participants
n=24 Participants
|
8 Participants
n=24 Participants
|
27 Participants
n=54 Participants
|
82 Participants
n=222 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=28 Participants
|
20 Participants
n=31 Participants
|
20 Participants
n=30 Participants
|
20 Participants
n=31 Participants
|
17 Participants
n=24 Participants
|
16 Participants
n=24 Participants
|
27 Participants
n=54 Participants
|
140 Participants
n=222 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
6 participants
n=28 Participants
|
15 participants
n=31 Participants
|
17 participants
n=30 Participants
|
11 participants
n=31 Participants
|
3 participants
n=24 Participants
|
1 participants
n=24 Participants
|
8 participants
n=54 Participants
|
61 participants
n=222 Participants
|
|
Region of Enrollment
Italy
|
4 participants
n=28 Participants
|
1 participants
n=31 Participants
|
2 participants
n=30 Participants
|
3 participants
n=31 Participants
|
3 participants
n=24 Participants
|
1 participants
n=24 Participants
|
8 participants
n=54 Participants
|
22 participants
n=222 Participants
|
|
Region of Enrollment
Denmark
|
2 participants
n=28 Participants
|
1 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=31 Participants
|
0 participants
n=24 Participants
|
1 participants
n=24 Participants
|
0 participants
n=54 Participants
|
4 participants
n=222 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=28 Participants
|
5 participants
n=31 Participants
|
2 participants
n=30 Participants
|
4 participants
n=31 Participants
|
0 participants
n=24 Participants
|
1 participants
n=24 Participants
|
2 participants
n=54 Participants
|
16 participants
n=222 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=28 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
3 participants
n=31 Participants
|
6 participants
n=24 Participants
|
5 participants
n=24 Participants
|
9 participants
n=54 Participants
|
29 participants
n=222 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=28 Participants
|
2 participants
n=31 Participants
|
1 participants
n=30 Participants
|
2 participants
n=31 Participants
|
1 participants
n=24 Participants
|
5 participants
n=24 Participants
|
7 participants
n=54 Participants
|
21 participants
n=222 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=28 Participants
|
2 participants
n=31 Participants
|
2 participants
n=30 Participants
|
6 participants
n=31 Participants
|
4 participants
n=24 Participants
|
4 participants
n=24 Participants
|
3 participants
n=54 Participants
|
23 participants
n=222 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=28 Participants
|
0 participants
n=31 Participants
|
2 participants
n=30 Participants
|
1 participants
n=31 Participants
|
1 participants
n=24 Participants
|
5 participants
n=24 Participants
|
0 participants
n=54 Participants
|
11 participants
n=222 Participants
|
|
Region of Enrollment
Poland
|
1 participants
n=28 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=31 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
1 participants
n=54 Participants
|
2 participants
n=222 Participants
|
|
Region of Enrollment
Portugal
|
0 participants
n=28 Participants
|
3 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=31 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
0 participants
n=54 Participants
|
3 participants
n=222 Participants
|
|
Region of Enrollment
Slovenia
|
0 participants
n=28 Participants
|
1 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=31 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
0 participants
n=54 Participants
|
1 participants
n=222 Participants
|
|
Region of Enrollment
Greece
|
0 participants
n=28 Participants
|
0 participants
n=31 Participants
|
1 participants
n=30 Participants
|
0 participants
n=31 Participants
|
2 participants
n=24 Participants
|
0 participants
n=24 Participants
|
0 participants
n=54 Participants
|
3 participants
n=222 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=28 Participants
|
0 participants
n=31 Participants
|
2 participants
n=30 Participants
|
0 participants
n=31 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
0 participants
n=54 Participants
|
2 participants
n=222 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=28 Participants
|
0 participants
n=31 Participants
|
1 participants
n=30 Participants
|
1 participants
n=31 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
0 participants
n=54 Participants
|
2 participants
n=222 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=28 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=31 Participants
|
1 participants
n=24 Participants
|
0 participants
n=24 Participants
|
2 participants
n=54 Participants
|
3 participants
n=222 Participants
|
|
Region of Enrollment
Japan
|
0 participants
n=28 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=31 Participants
|
2 participants
n=24 Participants
|
1 participants
n=24 Participants
|
6 participants
n=54 Participants
|
9 participants
n=222 Participants
|
|
Region of Enrollment
Switzerland
|
0 participants
n=28 Participants
|
1 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=31 Participants
|
1 participants
n=24 Participants
|
0 participants
n=24 Participants
|
1 participants
n=54 Participants
|
3 participants
n=222 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=28 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=31 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
1 participants
n=54 Participants
|
1 participants
n=222 Participants
|
|
Region of Enrollment
Argentina
|
0 participants
n=28 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=31 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
5 participants
n=54 Participants
|
5 participants
n=222 Participants
|
|
Region of Enrollment
India
|
0 participants
n=28 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=31 Participants
|
0 participants
n=24 Participants
|
0 participants
n=24 Participants
|
1 participants
n=54 Participants
|
1 participants
n=222 Participants
|
PRIMARY outcome
Timeframe: 1 year after the consitution of the panel of expertsPopulation: For example: the 28 experts of the consensus panel involved in providing guidelines for time-to-event outcomes in Sarcoma and GIST trials provided recommandations for the definitions of 12 time to event outcomes to be used in randomized trials for sarcomas and GISTs. The precise definition of each outcome can be found in the publications.
Number of time-to-event outcomes defined following the consensus process
Outcome measures
| Measure |
Sarcoma and GIST
n=28 Participants
Sarcoma and GIST: No Intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
Breast Cancer
n=31 Participants
Breast cancer: No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
Pancreatic Cancer
n=33 Participants
Pancreatic cancer: No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
Renal Cell Carcinoma
n=36 Participants
Renal cell carcinoma: No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
Colon Cancer (Adjuvant Setting)
n=24 Participants
Colon cancer: No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy (adjuvant setting).
|
Solid Tumours Undergoing Image-guided Tumor Ablation
n=36 Participants
No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
|
(Early) Non Small Cell Lung Cancer
n=54 Participants
Experts involved in the consensus process for providing recommandations for the definitions of time to event outcomes to be used in randomized trials for patients with (early) Non Small Cell Lung Cancer
|
|---|---|---|---|---|---|---|---|
|
Number of Outcomes Defined Following the Consensus Process
|
12 Time to event outcomes
|
11 Time to event outcomes
|
14 Time to event outcomes
|
7 Time to event outcomes
|
5 Time to event outcomes
|
4 Time to event outcomes
|
19 Time to event outcomes
|
Adverse Events
Sarcoma and GIST
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Breast Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pancreatic Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Renal Cell Carcinoma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Colon Cancer (Adjuvant Setting)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Solid Tumours Undergoing Image-guided Tumor Ablation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
(Early) Non Small Cell Lung Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Carine Bellera
Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR
Phone: +33 (0)5 56 33 33 33
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place