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Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
EU CTIS ID: 2024-515344-23-00
What this study is testing
1: Evaluating the efficacy of the Gembrax/Folfirinox chemotherapy sequence 2: To assess the tolerability of MRI-guided adaptive stereotactic radiotherapy in non-progressive patients after SEQ 1.
- Therapeutic exploratory (Phase II)
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
- Patient between 18 and 75 years of age on the date of signing the consent form
- Histologically or cytologically proven pancreatic adenocarcinoma.
- Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 1
- Non-resectability criteria, according to NCCN 1.2015 recommendations (Appendix 14) validated during centralized review.
- Non-metastatic patient confirmed by TAP scan and liver MRI
- Feasibility of MRI-guided radiotherapy confirmed by centralized review
You likely can't join if
- Any previous treatment for pancreatic cancer (chemotherapy, radiotherapy, surgery, targeted therapy or experimental therapy, etc.).
- Other concomitant cancer or history of cancer, with the exception of treated cervical cancer in situ, basal or squamous cell skin carcinoma, superficial bladder tumor (Ta, Tis, and T1) or curatively treated tumor of good prognosis without chemotherapy and without evidence of disease within 3 years prior to inclusion.
- History of radiotherapy leading to a foreseeable overlap with the radiotherapy treatment under study (history of abdominal irradiation)
- Peripheral neuropathy ≥ grade 2
- ECG with QTc interval greater than 450 ms for men and greater than 470 ms for women
- Intolerance or allergy to one of the study drugs (gemcitabine, Nab-paclitaxel, oxaliplatin, irinotecan, 5-FU) or to an excipient of one of the drugs (e.g. fructose) described in the Contraindications or Warnings and Special Precautions sections of the SPCs or Prescribing Information.
See the full eligibility criteria
- Patient between 18 and 75 years of age on the date of signing the consent form
- Histologically or cytologically proven pancreatic adenocarcinoma.
- Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 1
- Non-resectability criteria, according to NCCN 1.2015 recommendations (Appendix 14) validated during centralized review.
- Non-metastatic patient confirmed by TAP scan and liver MRI
- Feasibility of MRI-guided radiotherapy confirmed by centralized review
- CA 19.9 < 500 IU/mL (without icteric cholestasis). If CA 19.9 between 500 IU/mL and 1000 IU/mL, patient may be included if PET scan and peritoneal MRI (peritoneal MRI optional) show no distant metastasis. If CA 19.9 >1000 IU/ML, the patient cannot be included.
- Any previous treatment for pancreatic cancer (chemotherapy, radiotherapy, surgery, targeted therapy or experimental therapy, etc.).
- Other concomitant cancer or history of cancer, with the exception of treated cervical cancer in situ, basal or squamous cell skin carcinoma, superficial bladder tumor (Ta, Tis, and T1) or curatively treated tumor of good prognosis without chemotherapy and without evidence of disease within 3 years prior to inclusion.
- History of radiotherapy leading to a foreseeable overlap with the radiotherapy treatment under study (history of abdominal irradiation)
- Peripheral neuropathy ≥ grade 2
- ECG with QTc interval greater than 450 ms for men and greater than 470 ms for women
- Intolerance or allergy to one of the study drugs (gemcitabine, Nab-paclitaxel, oxaliplatin, irinotecan, 5-FU) or to an excipient of one of the drugs (e.g. fructose) described in the Contraindications or Warnings and Special Precautions sections of the SPCs or Prescribing Information.
- Pregnant or breast-feeding woman. If a patient is of childbearing age, she must have a negative pregnancy test (serum β-hCG) documented 72 hours prior to inclusion.
- Brivudine-based treatment within 4 weeks before or after 5-fluorouracil treatment (potentially fatal interaction).
- Patient having received a live attenuated vaccine within 10 days prior to inclusion and up to 6 months following cessation of chemotherapy.
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.