Small Bowel AdenocarcinomaPhase 3BALLADNCT02502370
Phase III Trial Investigating the Potential Benefit of Adjvant Chemotherapy for Small Bowel Adenocarcinoma
A Phase 3 study testing observation alone, LV5FU2 and FOLFOX in people with Small Bowel Adenocarcinoma and Adjuvant Chemotherapy for SBA, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Adenocarcinoma, Adjuvant Chemotherapy for SBA
- What is being tested?
- observation alone, LV5FU2 and FOLFOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- R0 resected stage I, II or III small bowel adenocarcinoma
- No evidence of residual or metastatic disease at laparotomy and CT/MRI imaging of chest, abdomen and pelvis.
- Patients must be registered and randomised within 12 weeks of surgery and commence chemotherapy within 14 weeks of surgery
- ECOG Performance Status of 0 or 1
- Absolute neutrophil account ≥ 1.5 x109/l
- Platelet count ≥ 100 x 109/l
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- Haemoglobin ≥90 g/l (previous transfusion is allowed)
- AST and ALT ≤ 2.5 x upper limit of normal (ULN). (At least one of ALT or AST MUST be performed)
- Creatinine clearance > 50 ml/min (calculated by Cockcroft Gault or Wright equation) or measured by EDTA
- Serum bilirubin ≤ 1.5 x ULN
- Signed and dated informed consent indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrolment.
- Age ≥ 16 years
- Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures.
Who cannot join
- Non-adenocarcinoma histology of small bowel tumour which includes but is not confined to lymphoma, GIST, carcinoid or other neuroendocrine tumour, squamous carcinoma, melanoma or sarcoma.
- Previous neo-adjuvant chemo(radio)therapy for small bowel adenocarcinoma
- Clinically significant cardiovascular disease (i.e. active or < 12 months since cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association [NYHA] grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension)
- Pregnancy/lactation or of child bearing potential and not using medically approved contraception. (Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential)
- Previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease free interval of at least 3 years and treatment was with curative intent
- Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency
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- Known untreated coeliac disease (may be enrolled if diet controlled), untreated chronic inflammatory bowel disease or other cause of malabsorption or intestinal obstruction
- Grade ≥ 2 peripheral neuropathy
- Administration of any investigational drug within 28 days or 5 half-lives, whichever is longer, prior to receiving the first dose of trial treatment.
- Previous hypersensitivity to platinum salts
- Patients with clinically significant active infections, or any other serious medical condition in which chemotherapy is contraindicated will be excluded
- Patients with untreated vitamin B12 deficiency are excluded from receiving folinic acid as part of their chemotherapy regimen. However, these patients may be eligible for treatment with capecitabine fluoropyrimidine therapy, where no folinic acid is administered as part of the treatment regimen
Trial locations and contacts
1 site in 1 country.
France1 site
CHU du Bocage
Dijon, 21079
Côme LEPAGE, 33 3 80 39 34 86, ome.lepage@u-bourgogne.fr
About this study
Official title: PRODIGE 33 - BALLAD - Phase III Trial Investigating the Potential Benefit of Adjvant Chemotherapy for Small Bowel Adenocarcinoma
The 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.
- Being tested
- observation alone, LV5FU2, FOLFOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation aloneDrug
LV5FU2Drug
FOLFOXDrug
| Study group | Role | What they receive |
|---|---|---|
| Group1 Arm A Observation | Active comparator | Not described Receives: Drug: observation alone |
| Group 1 Arm B LV5FU2 | Experimental | Not described Receives: Drug: LV5FU2 |
| Group 2 Arm C LV5FU2 | Active comparator | Not described Receives: Drug: LV5FU2 |
| Group 2 ARM D FOLFOX | Experimental | Not described Receives: Drug: FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 3-year disease-free survival
Measured: 3 years
Overall survival
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Primary completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Bowel AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502370
- Sponsor's protocol ID
- PRODIGE 33 - BALLAD
- Acronym
- BALLAD
- Status last verified
- Jul 2015
- First submitted
- 15 Jul 2015
- Last updated
- 20 Jul 2015
- Results posted
- No
Publications
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.
PubMed 30590606
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRODIGE 33 - BALLAD - Phase III Trial Investigating the Potential Benefit of Adjvant Chemotherapy for Small Bowel Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02502370
- Acronym / sponsor ID
- BALLAD / PRODIGE 33 - BALLAD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Primary completion
- Sep 2023 (estimated)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1 Arm A Observation | Active comparator | Drug: observation alone |
| Group 1 Arm B LV5FU2 | Experimental | Drug: LV5FU2 |
| Group 2 Arm C LV5FU2 | Active comparator | Drug: LV5FU2 |
| Group 2 ARM D FOLFOX | Experimental | Drug: FOLFOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- R0 resected stage I, II or III small bowel adenocarcinoma
- No evidence of residual or metastatic disease at laparotomy and CT/MRI imaging of chest, abdomen and pelvis.
- Patients must be registered and randomised within 12 weeks of surgery and commence chemotherapy within 14 weeks of surgery
- ECOG Performance Status of 0 or 1
- Absolute neutrophil account ≥ 1.5 x109/l
Key exclusion criteria (12 listed)
- Non-adenocarcinoma histology of small bowel tumour which includes but is not confined to lymphoma, GIST, carcinoid or other neuroendocrine tumour, squamous carcinoma, melanoma or sarcoma.
- Previous neo-adjuvant chemo(radio)therapy for small bowel adenocarcinoma
- Clinically significant cardiovascular disease (i.e. active or < 12 months since cerebrovascular accident, myocardial infarction, unstable angina, New York Heart Association [NYHA] grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension)
- Pregnancy/lactation or of child bearing potential and not using medically approved contraception. (Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential)
- Previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease free interval of at least 3 years and treatment was with curative intent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observation alone | Drug | Group1 Arm A Observation |
| LV5FU2 | Drug | Group 1 Arm B LV5FU2, Group 2 Arm C LV5FU2 |
| FOLFOX | Drug | Group 2 ARM D FOLFOX |
Primary outcome
The 3-year disease-free survival
Time frame: 3 years
Overall survival
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2015.
- Derived from this study: PubMed 30590606Kitahara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing observation alone, LV5FU2 and FOLFOX in people with Small Bowel Adenocarcinoma and Adjuvant Chemotherapy for SBA, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martina SCHNEIDER (33 3 80 39 34 83, martina.schneider@u-bourgogne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 3-year disease-free survival (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02502370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2015.