Adjuvant chemotherapy for ampullary cancer after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hepatic artery infusion therapy for liver metastases after pancreatic/duodenal cancer surgery

  This study tests whether delivering chemotherapy directly to the liver via a pump can help people with pancreatic or duodenal cancer that has spread mainly to the liver after surgery and prior chemotherapy.

  Recruiting AdventHealth · Orlando, Florida · NCT07845617

• Planned surgery or focused local treatment after chemo for metastatic upper-GI adenocarcinoma with undetectable ctDNA

  This test sees if adding planned surgery or local treatments after three months of chemotherapy helps people with metastatic upper-gastrointestinal adenocarcinomas who have undetectable ctDNA.

  Recruiting Phase 2 Yale University · New Haven, Connecticut · NCT07282912

• Adjuvant mFOLFIRINOX versus capecitabine or gemcitabine for resected ampullary adenocarcinoma

  This trial will test whether giving modified FOLFIRINOX after surgery lowers the chance of cancer returning compared with capecitabine or gemcitabine in adults with resected ampullary adenocarcinoma.

  Recruiting Phase 3 Centre Hospitalier Universitaire Dijon · Dijon · NCT06813976

• Total pancreatectomy with islet autotransplantation for cancers in the pancreatic head at high risk of postoperative fistula

  This trial tests whether removing the whole pancreas and immediately transplanting the patient's own insulin-producing cells into the liver helps people with resectable cancers of the pancreatic head, duodenum, or ampulla who are at high risk for dangerous post-surgery pancreatic leaks.

  Recruiting Phase 1/2 University Hospital, Lille · Lille · NCT05116072

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.