Adjuvant chemotherapy for ampullary cancer after surgery
The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer. A Pan-European Prospective Multicenter Double Single Arm Cohort Study.
Fondazione Poliambulanza Istituto Ospedaliero · NCT06068023
This study is testing if personalized chemotherapy after surgery can help people with ampullary cancer live longer and feel better, based on their specific tumor type.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Fondazione Poliambulanza Istituto Ospedaliero (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Brescia, BS) |
| Trial ID | NCT06068023 on ClinicalTrials.gov |
What this trial studies
The ADAPTA study focuses on patients with resected ampullary adenocarcinoma, a rare gastrointestinal cancer, to evaluate the effectiveness of tailored adjuvant chemotherapy based on tumor subtype. It includes 200 patients, with half receiving CAPOX for intestinal subtype and the other half receiving FOLFIRINOX for pancreatobiliary and mixed subtypes. The study aims to improve survival rates by comparing outcomes with historical data from patients not treated with this regimen. Additionally, molecular sub-studies will provide deeper insights into the disease.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed ampullary adenocarcinoma who have undergone curative resection and are able to receive adjuvant chemotherapy.
Not a fit: Patients who have had prior treatment for ampullary cancer or those with serious concomitant systemic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve survival rates for patients with ampullary adenocarcinoma by providing more effective, tailored chemotherapy options.
How similar studies have performed: While there have been no prospective studies specifically addressing adjuvant chemotherapy for ampullary adenocarcinoma, similar approaches in other gastrointestinal cancers have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with histologically or cytologically confirmed AAC with subtyping of pancreatobiliary/mixed subtype or intestinal subtype * After curative resection for ampullary cancer without metastatic disease. * WHO performance status 0 or 1 * Able and willing to receive adjuvant chemotherapy * R0/ R1 resection * Age ≥ 18 years * Written informed consent Exclusion Criteria: * Prior radiotherapy, chemotherapy, or resection for AAC. * Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 5 years before diagnosis of AAC. * Pregnancy. * R2 resection. * Adjuvant chemotherapy started more than 12 weeks after surgery (aim to start within 8 weeks) * Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator. * Known hypersensitivity or contraindications against capecitabine, 5 FU, Irinotecan, or Oxaliplatin * Inadequate organ functions, characterized by: * Leucocytes (WBC) \< 3.0 X 109/l * Neutrophils \< 1.500 (count per microliter of blood) * Platelets \< 100 x 109 /l * Hemoglobin \< 8 mmol/l * Renal function: E-GFR \< 50 ml/min (serum creatinine \< 1.5 x UNL) * cholestasis with elevated levels of bilirubin and/or alkaline phosphatase \> 3x UNL (can be improved by biliary drainage if necessary) * elevated transaminases (ALAT/ASAT) ≥ 5 x UNL * hypoalbuminemia \< 2.5 g/dl * Inadequate coagulation status INR \> 2 or Quick \< 50%, aPTT \>50 sec in the absence of any drugs interfering with coagulation such as acenocoumarin, warfarin, phenprocoumon, NMH or UFH.
Where this trial is running
Brescia, BS
- Fondazione Poliambulanza — Brescia, BS, Italy (RECRUITING)
Study contacts
- Principal investigator: Moh'd Abu Hilal, MD, PhD — Fondazione Poliambulanza Instituto Ospedaliero
- Study coordinator: Moh'd Abu Hilal, MD, PhD
- Email: abuhilal9@gmail.com
- Phone: +393756326711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ampullary Adenocarcinoma, pancreatobiliary-type, intestinal-type, mixed/hybrid-type, adjuvant chemotherapy, CAPOX, FOLFIRINOX