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A Trial to Evaluate the Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma

NCT04257461 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-06

No results posted yet for this study

Summary

An open-label, randomised, controlled, multi-centre, trial with disease free survival as the primary end point. The worldwide collaboration is referred to as GLOBAL BALLAD and consists of a number of individual parallel prospective studies addressing the same objectives with similar designs brought together under the framework of the International Rare Cancer Initiative. This protocol is for BALLAD BELGIUM, which is the component of GLOBAL BALLAD.

Conditions

  • Small Bowel Adenocarcinoma

Interventions

DRUG

Fluoropyrimidine

Monotherapy: 12 cycles of 5FU or 8 cycles of Capecitabine. The choice of fluoropyrimidine must be specified prior to randomisation.

DRUG

Oxaliplatin

Bichemotherapy: Oxaliplatine combined with Fluoropyrimidine.

Sponsors & Collaborators

  • Kom Op Tegen Kanker

    collaborator OTHER

  • Cancer Research UK

    collaborator OTHER

  • Belgian Group of Digestive Oncology

    lead OTHER

Principal Investigators

  • Timon Vandamme, Prof · Coordinating Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-20
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04257461 on ClinicalTrials.gov