Trial · NCT04257461
A Trial to Evaluate the Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma
NCT04257461, Phase 3, Unknown, Belgian Group of Digestive Oncology
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial to Evaluate the Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma. Trials, record NCT04257461. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04257461
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Evaluate the Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma
- NCT number
- NCT04257461
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Belgian Group of Digestive Oncology
- Conditions
- Small Bowel Adenocarcinoma
- Interventions
- Fluoropyrimidine, Oxaliplatin
- First posted
- 2020-02-06
- Last updated
- 2025-02-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | efficacy assessed by the 3-year Disease-free survival | 3 years from randomisation | This is defined as time from randomisation to the first occurrence of the following events: * Disease relapse (confirmed by imaging) * Incidence of a new primary (confirmed by imaging and histology/cytology) * Death from any cause |
| Secondary | efficacy assessed by the overall survival | 5 years from randomisation | The patient's survival status is determined at each follow-up visit. After the mandated clinic visits survival status data will come from responsible cancer centres, cancer registries and national databases and include long-term passive follow-up data. |
| Secondary | safety assessed by the toxicity of chemotherapy | until 1 month after treatment | Toxicity will be assessed using CTCAE version 4.0. Only toxicities that are at least grade 2 will be recorded on the CRF |
| Secondary | quality of life as assessed using the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Core 30 | until end of study, up to 5 years from randomisation | This will be completed at 9, 12, 18 and 24 months post randomisation for all arms of the trial. Minimum and maximum values do not apply for this scale. |
| Secondary | quality of life as assessed using the EORTC (European Organisation for Research and Treatment of Cancer) Quality of Life Questionnaire Colo-Rectal module 29 | until end of study, up to 5 years from randomisation | This will be completed at 9, 12, 18 and 24 months post randomisation for all arms of the trial. Minimum and maximum values do not apply for this scale. |
| Secondary | quality of life as assessed using the EuroQol 5 dimension scale (EQ-5D) | until end of study, up to 5 years from randomisation | This will be completed at 9, 12, 18, 24, 30, 36, 48, 60 72 and 84 months post randomisation for all arms of the trial. Minimum and maximum values do not apply for this scale. |
| Secondary | Exploratory: clinical applicability of the study results assessed by the translational research on blood and tissue | Will be collected at the end of study, up to 5 years from randomisation | The aim is to establish a biobank of SBA tissue and blood with complete and comprehensive trial quality follow-up data which may act as the foundation for many future collaborative research projects and for combined projects with other funded tissue collections. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04257461
GET https://conductscience.org/api/trials/v1/NCT04257461/registered