Combining mFOLFIRINOX and radiotherapy for advanced pancreatic cancer with normal CA19-9 levels

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

This study evaluates the effectiveness of mFOLFIRINOX chemotherapy combined with radiotherapy in patients diagnosed with advanced pancreatic adenocarcinoma who have normal levels of the CA19-9 biomarker. Given that a significant portion of pancreatic cancer patients may present with normal CA19-9 levels, this trial aims to determine if this specific group responds better to the combined treatment approach. The study will measure progression-free survival, overall survival, and other response rates to assess the treatment's efficacy. Participants must meet specific eligibility criteria, including age and health status, to ensure safety and reliability of results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document.
* Age ≥ 18 years and ≤ 80 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
* Patients who have not received any form of anti-tumor therapy.
* Baseline serum CA19-9 ≤ 37 U/mL, CEA≤ 5.2 ng/mL, and CA125 ≤ 35 U/mL.
* Presence of at least of one measurable lesion in agreement to RECIST criteria.
* The expected survival ≥ 3 months.
* Adequate organ performance based on laboratory blood tests.
* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria:

* Pregnant or nursing women.
* Patients who have received any form of anti-tumor therapy.
* Baseline serum CA19-9 \> 37 U/mL, CEA \> 5.2 ng/mL, or CA125 \> 35 U/mL.
* The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
* Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
* Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
* Renal insufficiency or dialysis
* Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
* Patients who are allergic to oxaplatin or other chemotherapy drugs.
* Patients who are unwilling or unable to comply with study procedures.

Where it's running

• Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Guopei Luo, MD — Fudan University
• Study coordinator: Ying Yang, MD
• Email: yangying@fudanpci.org
• Phone: 86 64175590

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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.