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PRODIGE 33 - BALLAD - Phase III study to evaluate the benefit of adjuvant chemotherapy in small bowel adenocarcinoma.
EU CTIS ID: 2024-515299-11-00
What this study is testing
- To evaluate the efficacy of 12 cycles (or 8 cycles if capecitabine) of adjuvant chemotherapy versus observation alone after resection of stage I-III small bowel adenocarcinoma (SBI). - To evaluate the efficacy of 12 cycles (or 8 cycles if capecitabine) of adjuvant treatment with 5-FU or capecitabine monotherapy versus 5-FU or capecitabine plus oxaliplatin after resection of stage I-III small bowel adenocarcinoma (SBA).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- R0 resected stage I, II, III small bowel adenocarcinoma (SBA)
- Dated and signed informed consent prior to inclusion
- No residual or metastatic disease visible on CT/MRI TAP
- Patient to be registered and randomised within 12 weeks of surgery, and able to start chemotherapy within 14 weeks of surgery
- ECOG ≤ 1
- Age ≥ 18 years
You likely can't join if
- Small bowel tumour with non-adenocarcinoma histology, including but not limited to lymphoma, GIST, carcinoid or other neuroendocrine tumours, squamous cell carcinoma, melanoma and sarcoma.
- Known hypersensitivity to platinum salts
- Patients with an active, clinically significant infection or any other serious medical condition for which chemotherapy is contraindicated
- Patients with untreated vitamin B12 deficiency should not receive chemotherapy containing folinic acid. However, this patient may be eligible for capecitabine-based chemotherapy.
- Patients with clinically significant neurosensorial hearing impairment should not receive oxaliplatin. However, this patient may be randomised in group 1 to either observation alone or fluoropyrimidine monotherapy.
- Inability to comply with scheduled visits, therapeutic regimens, biological examinations and any other study procedures.
See the full eligibility criteria
- R0 resected stage I, II, III small bowel adenocarcinoma (SBA)
- Dated and signed informed consent prior to inclusion
- No residual or metastatic disease visible on CT/MRI TAP
- Patient to be registered and randomised within 12 weeks of surgery, and able to start chemotherapy within 14 weeks of surgery
- ECOG ≤ 1
- Age ≥ 18 years
- Biological tests: neutrophils ≥ 2000/mm3; platelets ≥ 100000/mm3; haemoglobin ≥ 9 g/dL (prior transfusion possible) and bilirubin ≤ 1.5 x ULN.
- ASAT et ALAT ≤ 2,5 x LSN
- Creatinine clearance > 50 mL/min (calculated using the Cockcroft Gault formula)
- Women of childbearing potential (post-menopausal women must have been amenorrhoeic for at least 12 months to be considered not of childbearing potential) must use contraception during treatment and for at least 4 months after stopping treatment; for male patients, contraception must be used during treatment and for at least 6 months after stopping treatment.
- Small bowel tumour with non-adenocarcinoma histology, including but not limited to lymphoma, GIST, carcinoid or other neuroendocrine tumours, squamous cell carcinoma, melanoma and sarcoma.
- Known hypersensitivity to platinum salts
- Patients with an active, clinically significant infection or any other serious medical condition for which chemotherapy is contraindicated
- Patients with untreated vitamin B12 deficiency should not receive chemotherapy containing folinic acid. However, this patient may be eligible for capecitabine-based chemotherapy.
- Patients with clinically significant neurosensorial hearing impairment should not receive oxaliplatin. However, this patient may be randomised in group 1 to either observation alone or fluoropyrimidine monotherapy.
- Inability to comply with scheduled visits, therapeutic regimens, biological examinations and any other study procedures.
- Neoadjuvant chemo(radio)therapy for SBA
- Clinically significant cardiovascular disease: active or < 12 months since stroke, myocardial infarction, unstable angina, congestive heart failure NYHA grade II or higher, severe cardiac arrhythmia requiring treatment, or uncontrolled hypertension.
- History of cancer, except treated carcinoma in situ of the uterine cervix or basal or squamous cell carcinoma of the skin, unless treated with curative intent and considered cured for at least 3 years.
- Partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency, defined by uracilemia ≥ 16ng/ml
- Known untreated celiac disease (inclusion possible if controlled by diet), untreated chronic inflammatory bowel disease, or other causes of malabsorption or intestinal obstruction.
- Peripheral neuropathy grade ≥ 2
- Pregnant and breast-feeding women
- Administration of any other investigational drug within 28 days prior to the first cycle of study treatment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.