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BALLAD
PRODIGE 33 - BALLAD - Phase III Trial Investigating the Potential Benefit of Adjvant Chemotherapy for Small Bowel Adenocarcinoma
Sponsor study identifier
interventional
100
1 country
1
Study Start
Not reported
Date not reportedPrimary Completion
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedThe utility of adjuvant chemotherapy in the management of Small Bowel Adenocarcinoma (SBA) remains unproven and awaits the results of a large, global, prospective, phase III, randomised, controlled trial. Across the 830 million population of North America and Europe, there are approximately 3,000 patients with stage I-III SBA every year who would be potentially eligible for such an adjuvant chemotherapy trial. Given the absence of good-quality and evidence-based data, it has been agreed that a trial considering adjuvant chemotherapy versus no chemotherapy was appropriate for patients with stage I-III SBA in whom the oncologist and patient feel that the benefit of adjuvant chemotherapy is uncertain. For those patients with stage I-III SBA who, with their oncologists, feel that the potential benefit of adjuvant chemotherapy is certain (and hence are not willing to accept randomisation to the 'no chemotherapy' arm), a randomisation between single agent fluoropyrimidine versus doublet fluoropyrimidine and oxaliplatin chemotherapy will be offered. Tumour stage will be used as a stratification factor. Those patients who do not consent to be randomised will be offered registration to allow collection of demographic, clinicopathological and survival data, thereby making optimal use of the rare patient population available. In addition, archival Formalin Fixed Paraffin Embedded (FFPE) tissue and contemporaneous venous blood samples will be collected from every registered patient to allow molecular profiling and future translational research. A questionnaire about underlying risk factors (e.g. Crohn's disease, coeliac disease, Lynch syndrome etc) will be completed along with the other collected data on all registered patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 15, 2015
Actual (reported)July 20, 2015
Actual (reported)September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The 3-year disease-free survival
3 years
Overall survival
7 years
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
FOLINIC ACID
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
CAPECITABINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM COATED TABLET
View registry recordFormulated product
FLUOROURACIL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry recordFormulated product
FLUOROURACIL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry recordFormulated product
OXALIPLATIN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
FOLINIC ACID
Named ingredient: Folinic Acid
View registry recordCAPECITABINE
Named ingredient: Capecitabine
View registry recordFLUOROURACIL
Named ingredient: Fluorouracil
View registry recordFLUOROURACIL
Named ingredient: Fluorouracil
View registry recordOXALIPLATIN
Named ingredient: Oxaliplatin
View registry recordCHU du Bocage
Dijon, 21079, France
Kitahara H, Honma Y, Ueno M, Kanemitsu Y, Ohkawa S, Mizusawa J, Furuse J, Shimada Y; Colorectal Cancer Study Group and Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group. Randomized phase III trial of post-operative chemotherapy for patients with stage I/II/III small bowel adenocarcinoma (JCOG1502C, J-BALLAD). Jpn J Clin Oncol. 2019 Mar 1;49(3):287-290. doi: 10.1093/jjco/hyy188.
First Submitted
July 15, 2015
First Posted
July 20, 2015
Primary Completion
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 20, 2015
Record last verified: 2015-07
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
SOLUTION FOR INFUSION
Contact the study team to confirm eligibility.
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Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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