Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

Phase 1

• Conditions: local advenced pancreatic adenocarcinoma; MedDRA version: 21.0Level: LLTClassification code: 10033606Term: Pancreatic cancer non-resectable Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2024-515344-23-00
• Lead Sponsor: Institut Regional Du Cancer De Montpellier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-30
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 103

Inclusion 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.

Exclusion Criteria

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 ß-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified