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New treatment option for Resected Pancreatic Adenocarcinoma
Official title Risk-adapted Adjuvant Chemotherapy Guided by the Tumour Stage for Operated Pancreatic Adenocarcinoma Following Neoadjuvant Chemotherapy With mFOLFIRINOX
ClinicalTrials.gov ID: NCT07044453
What this study is testing
What is Gem/Nabpaclitaxel infusion?
Gem/Nabpaclitaxel infusion is an investigational medicine, being studied as a potential treatment for resected pancreatic adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Induction mFOLFIRINOX has become the standard in the management of locally advanced and borderline adenocarcinoma. Following the results of the PREOPANC-01 JASP-05, NEONAX studies it is expected that the neoadjuvant approach will be the standard strategy soon in patients with resectable PAC.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed resected pancreatic adenocarcinoma (R0 or R1) that has received 3 months of neoadjuvant mFOLFIRINOX, including anatomically...
- Performance status ECOG 0 or 1
- CA 19-9 level ≤ 200 U/ml
- Age 18 years or over
- Absolute neutrophil count \> 1,500 mm³, platelet count \> 100,000 mm³, creatinine clearance (according to MDRD equation) \> 50 ml/min, haemoglobin...
You likely can't join if
- Metastatic PAC on post-operative imaging
- Cholangiocarcinoma, ampullary carcinoma or other non-PAC pancreatic tumors
- Non-controlled congestive heart failure, non-treated angina, recent myocardial infarction (in the previous year), non-controlled AHT (SBP \> 160 mm...
- Major non-controlled infection, chronic infectious diseases, immune deficiency syndromes
- Premalignant hematologic disorders, e.g. myelodysplastic syndrome
- Severe liver failure
See the full eligibility criteria
- Histologically confirmed resected pancreatic adenocarcinoma (R0 or R1) that has received 3 months of neoadjuvant mFOLFIRINOX, including anatomically resectable and borderline resectable tumors, in accordance with the...
- Performance status ECOG 0 or 1
- CA 19-9 level ≤ 200 U/ml
- Age 18 years or over
- Absolute neutrophil count \> 1,500 mm³, platelet count \> 100,000 mm³, creatinine clearance (according to MDRD equation) \> 50 ml/min, haemoglobin level \> 10 g/dl (transfusions are authorized)
- Women of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile): with highly effective...
- For men participating in the study, contraception is required during the trial and for 12 months after stopping chemotherapy treatment.
- Patient affiliated with, or beneficiary of, a social security (national health insurance) plan
- Patient able to comply with the study protocol, in the investigator's judgment
- Read and understood the information letter and signed the consent form
- Metastatic PAC on post-operative imaging
- Cholangiocarcinoma, ampullary carcinoma or other non-PAC pancreatic tumors
- Non-controlled congestive heart failure, non-treated angina, recent myocardial infarction (in the previous year), non-controlled AHT (SBP \> 160 mm Hg or DBP \> 100 mm Hg, despite optimal drug treatment), long QT
- Major non-controlled infection, chronic infectious diseases, immune deficiency syndromes
- Premalignant hematologic disorders, e.g. myelodysplastic syndrome
- Severe liver failure
- Past or current history of malignancies except for the indication under this study and curatively treated basal and squamous cell carcinoma of the skin, in situ carcinoma of the cervix, other malignant disease without...
- Any medical, psychological or social situation that (in the investigator's opinion) could limit the patient's compliance with the protocol or the ability to obtain or interpret data or to understand the conditions...
- Pregnant or breastfeeding women and women of childbearing age not using effective means of contraception
- Person participating in another treatment research having the same primary endpoint
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship
- Uracilemia ≥ 150 ng/ml (suggestive of complete DPD deficiency)
- Contraindication to study adjuvant chemotherapy treatments in accordance with the SmPCs of the products used in this trial (Gemcitabine, Nab-Paclitaxel, Oxaliplatin, Folinic Acid or Leucovorin, Irinotecan, Fluorouracil)
The study team makes the final eligibility decision.
Where it's taking place
- Rouen, France
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rouen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.