Locally advanced adenocarcinoma of pancreas MedDRA version: 21.0 Level: LLT Classification code 10033600 Term: Pancreatic adenocarcinoma non-resectable System Organ Class: 100000004864
Conditions
Interventions
Product Name: Gemcitabine
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: GEMCITABINE
CAS Number: 95058-81-4
Trade Name: Abraxane
Pharmaceutical Form:
Pro
Sponsors
Institut régional du cancer de Montpellier (ICM)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient between 18 and 75 years of age on the date of signing the consent form. 2.Histologically or cytologically proven pancreatic adenocarcinoma. 3.Eastern Cooperative Oncology Group (ECOG) performance status = 1. 4.Non-resecurability criteria, according to NCCN 1.2015 recommendations validated during the centralized proofreading. 5.Non-metastatic patient confirmed by TAP scan and hepatic MRI. 6.Feasibility of MRI-guided radiotherapy confirmed by central review. 7.Uracilemia =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Any previous treatment for pancreatic cancer (chemotherapy, radiation therapy, surgery, targeted therapy or experimental therapy...) 2.Gilbert's syndrome known or homozygous for UGT1A1*28 validated 3.Other concomitant cancer or a history of cancer, with the exception of treated cervical cancer in situ, basal cell or squamous cell skin carcinoma, superficial bladder tumour (Ta, Tis, and T1) or a good prognosis tumour treated curatively without chemotherapy and without evidence of disease within 3 years prior to inclusion. 4.History of radiotherapy with predictable overlap with the radiotherapy treatment under study (history of abdominal irradiation). 5.Patients with high cardiovascular risk, including, but not limited to, coronary stent or myocardial infarction within the last 6 months. 6.Peripheral neuropathy = grade 2. 7.ECG with a QTc interval greater than 450 ms for males and greater than 470 ms for females. 8.Contraindication to MRI and MRI-guided radiation therapy. 9.History of chronic inflammatory disease of the colon or rectum. 10.Any other serious concomitant uncontrolled disease or disorder that may interfere with the patient's participation in the study and safety during the study (e.g., severe liver, kidney, lung, metabolic, or psychiatric disorders). 11.Intolerance or allergy to one of the study drugs (gemcitabine, Abraxane®, oxaliplatin, irinotecan, 5-FU) or to an excipient of one of the drugs (example: fructose) described in the Contraindications or Warnings and Special Precautions sections of the SPC or Prescribing Information. 12.Legal incapacity (patient under curatorship or guardianship). 13.Pregnant or breastfeeding woman. If a patient is of childbearing age, she must have a negative pregnancy test (serum ß-hCG) documented 72 hours prior to inclusion. 14.Patients using VKA (Coumadin...) (possible modification of treatment before inclusion). 15.Uncontrolled active bacterial or viral or fungal infection requiring systemic treatment. 16.Previous or known HIV infection. 17.History of peripheral arterial disease (e.g., claudication, Leo Buerger's disease). 18.Patient who received live attenuated vaccine within 10 days prior to inclusion. 19.Patients with a history of pulmonary fibrosis or interstitial pneumonia. 20.Inability to undergo medical follow-up of the trial for geographical, social or psychological reasons. 21.Participation in another clinical study with an investigational product within the last 30 days prior to inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: For chemotherapy sequence: To evaluate the efficacy of the Gembrax/folfirinox chemotherapy sequence For Radiation Therapy: To evaluate the feasibility in terms of safety of LInac MRI radiotherapy (RT) in non-progressive patients after chemotherapy sequence;Secondary Objective: For chemotherapy sequence: -To evaluate the tolerance of the chemotherapy sequence For radiotherapy : - To assess acute toxicity of radiotherapy - To evaluate dosimetric results - To correlate dosimetry results to tolerance and survival For the entire treatment (chemotherapy + radiotherapy) - To assess progression-free survival - To assess overall survival - To evaluate the tolerance of the entire treatment (Tox max) - To assess late toxicity - To evaluate the resection rate - To evaluate the evolution of the turnover marker 19.9 - To assess Quality of Life ;Primary end point(s): For chemotherapy Sequence: -Non-progression rate at 4 months according to the RECIST 1.1 criteria. For radiotherapy: -Rate of acute digestive non-toxicity in the 90 days of grade 3 or 4 evaluated by the NCI CTC AE v5.0 classification ;Timepoint(s) of evaluation of this end point: -Non-progression rate evaluated at 4 months -Rate of grade 3-4 acute digestive non-toxicity evaluated at 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For chemotherapy Sequence: -Tolerance of the chemotherapy sequence as assessed by the NCI CTC AE v5.0 classification. For radiotherapy : - Tolerance (acute and late toxicities) of the radiotherapy sequence as assessed by NCI CTC AE v5.0. - Collection of dosimetric results obtained in terms of dose/volume on predictive dosimetry (coverage of VTP by the prescription dose on totalized dosimetry, dose received at the VWG...) - Collection and somation of the dosimetric results obtained in terms of dose/volume for adaptive radiotherapy sessions and comparison with predictive dosimetry - Correlation of dose to organs at risk (duodenum, small intestine, stomach, colon) to the occurrence of digestive toxicities (predictive and adaptive dosimetry) - Correlation of VTP coverage and VWG dose to progression-free survival and overall survival (predictive and adaptive dosimetry) For the entire therapeutic sequence (chemotherapy Sequence + radiotherapy) - Progression-free survival defined as the period of time between the inclusion date and the date of the 1st documented progression or the date of death from any cause. - Global survival defined as the time between the inclusion date and the date of death from all causes. - Overall Treatment Tolerance as assessed by NCI CTC AE v5.0 classification. - Resection rate defined as the percentage of patients operated on during treatment and up to 6 months post-radiation therapy. - Assess the prognostic impact of the evolution of CA 19.9 on survival - Quality of Life scores assessed by the EORTC QLQ-C30 and QLQ-PAN26 questionnaires at baseline, 2 months (at the end of Cycle 1), 4 months (at the end of Cycle 2), and at follow-up every 6 weeks after RT. ;Timepoint(s) of evaluation of this end point: -At the end of chemotherapy sequence -At the end of radiotherapy | — |
Countries
France
Contacts
Public ContactDr Jean-Pierre Bleuse
Institut régional du cancer de Montpellier
Outcome results
None listed