Locally Advanced Pancreatic Adenocarcinoma Clinical Trial
— GABRINOX-ARTOfficial title:
Phase II Study to Assess the Interest of a Sequential Treatment With Gemcitabine/Nab-paclitaxel (GEMBRAX) and Then FOLFIRINOX Followed by Stereotactic Magnetic Resonance-guided Adaptive Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
The aim of this study is to demonstrate the efficacy of intensified and sequential chemotherapy (Gabrinox) comprising Gembrax regimen (Gemcitabine-Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) in patients with locally advanced pancreatic adenocarcinoma. The study will also demonstrate the feasibility of combining this intensified chemotherapy with MRI-guided stereotactic radiotherapy in non-progressive patients after the chemotherapy by Gabrinox regimen.
Status | Recruiting |
Enrollment | 103 |
Est. completion date | June 2030 |
Est. primary completion date | January 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Patient aged from 18 to 75 years at the date of signature of the consent form 2. Histologically or cytologically proven pancreatic adenocarcinoma 3. Eastern Cooperative Oncology Group (ECOG) performance status = 1 4. Non-resectable tumour according to the National Comprehensive Cancer Network (NCCN) 1.2015 recommendations after external review of imaging data by multidisciplinary experts. 5. Non-metastatic cancer confirmed by thorax-abdomen-pelvis computerized tomography (CT) scan and liver MRI 6. SMART feasibility confirmed by centralized review 7. Uracilemia < 16 ng/ml 8. Hematological assessment within 14 days before inclusion, defined by: - Neutrophils = 2 000/mm3 (2 × 109/L); - Platelets = 100 000/mm3 (100 × 109/L); - Hemoglobin = 9 g/dl 9. Liver function (within 14 days before inclusion) defined by: - ASpartate Transaminase (AST) and ALanine Transaminase (ALT) = 2.5 x Upper Limit of Normal (ULN); - Total bilirubin = 1.5 x ULN. Patients with a metallic biliary prosthesis due to biliary obstruction caused by the cancer may be included, if: a CT scan with injection of contrast medium and thin pancreas sections was performed before placing the biliary prosthesis, the bilirubin level after prosthesis fitting decreased to =20 m /L (=34 µmol/l), and in the absence of cholangitis. 10. Creatininaemia within the reference limits, or calculated clearance =50 ml/min for patients with a serum creatinine value above or below the reference values (clearance calculated using the Chronic Kidney Disease EPIdemiology collaboration (CKDEPI formula). 11. Serum calcium AND magnesium AND potassium = Lower Limit Normal (LLN and = 1.2 x Upper Limit Normal (ULN) 12. Cancer Antigen (CA 19.9) <500 IU/mL (without cholestasis). Patients with CA 19.9 between 500 IU/mL and 1000 IU/mL can be included if the Positron Emission Tomography (PET) scan and peritoneal MRI (optional) do not detect any distant fixation, indicative of metastasis. Patients with CA 19.9 = 1000 IU/mL cannot be included. 13. Sexually active patients must use a contraceptive method considered adequate and suitable by the investigator during the entire period of administration of the study treatment and up to 6 months after the treatment end, for female and male patients. 14. Signature of the consent form before any study-specific procedure. 15. Covered by the French health insurance. Exclusion Criteria: 1. Any previous treatment for pancreatic cancer (e.g. chemotherapy, radiotherapy, surgery, targeted therapy, experimental therapy) 2. Gilbert's syndrome or homozygous Uridine DiPhosphate Glucuronosyl Transferase 1 A1 (UGT1A1 * 28) 3. Other concomitant cancer or history of cancer, except for treated in situ cancer of the cervix , basal cell or squamous cell carcinoma, superficial bladder tumour (Ta, Tis, and T1), or good-prognosis tumour cured without chemotherapy and without signs of disease in the 3 years before inclusion 4. History of radiotherapy that causes a foreseeable 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 in the past 6 months. 6. Peripheral neuropathy = grade 2 7. ECG with QTcorrected (QTc) interval longer than 450 ms for men and longer than 470 ms for women 8. Contraindication to MRI and MRI-guided radiotherapy 9. History of chronic inflammatory disease of the colon or rectum 10. Any other concomitant and not controlled serious illness or disturbance 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 disorder) 11. Intolerance or allergy to one of the study drugs (gemcitabine, Nab-paclitaxel, oxaliplatin, irinotecan, 5-FU) or to one of their excipients (e.g. fructose) listed in the Contraindications or Warnings sections and Special precautions of the Summary of Product Characteristics (SmPC) or prescription information 12. Legal incapacity (patient under guardianship or wardship) 13. Pregnant or breastfeeding woman. Fertile women must have a negative pregnancy test (serum ß-hCG) performed 72 hours before inclusion 14. Patient using vitamin K antagonists (Coumadin…) (possible modification of the treatment before inclusion) 15. Active and uncontrolled bacterial or fungal infection that requires systemic treatment. 16. Know active HIV infection 17. History of peripheral arterial disease (e.g. lameness, Buerger's disease). 18. Patient who received a attenuated live vaccine in the 10 days before inclusion 19. Patient with history of pulmonary fibrosis or interstitial pneumonia. 20. Inability to attend the follow-up visits due to geographic, social or mental reasons. 21. Participation in another clinical study with a research product during the last 30 days before inclusion. |
Country | Name | City | State |
---|---|---|---|
France | Centre Georges-François Leclerc | Dijon | Côte d'Or |
France | Institut Paoli Calmettes | Marseille | Bouches-du-Rhône |
France | CHU Saint-Eloi | Montpellier | Herault |
France | Institut régional du Cancer de Montpellier | Montpellier | Hérault |
France | CHU Carémeau | Nîmes | Gard |
France | Hôpital Pitié Salpétriêre | Paris |
Lead Sponsor | Collaborator |
---|---|
Institut du Cancer de Montpellier - Val d'Aurelle |
France,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of non-progression at 4 months | (Sequence 1 success = chemotherapy) according to the RECIST v1.1 criteria | 4 months | |
Primary | Acute gastrointestinal non-toxicity rate | Absence of toxicity of grade =3 related to radiotherapy within 90 days, evaluated using the NCI-CTCAE v5.0 classification (sequence 2 success = radiotherapy) | 90 days | |
Secondary | Assessment of adverse events due to chemotherapy by using the NCI-CTCAE version 5.0 scale | Adverse events of chemotherapy evaluated using the NCI-CTCAE v5.0 classification | 36 months | |
Secondary | Assessment of adverse events due to radiotherapy by using the NCI-CTCAE version 5.0 | Adverse events of radiotherapy evaluated using the NCI-CTCAE v5.0 classification | 36 months | |
Secondary | Progression-free Survival (PFS) | Between the date of inclusion and the date of the first documented progression or the date of death from any cause | Through study completion, an average of 72 months | |
Secondary | Overall Survival (OS) | Interval between the date of inclusion and the date of death from any cause | Through study completion, an average of 72 months | |
Secondary | Resection rate | Percentage of patients who undergo tumour surgery up to 6 months post-radiotherapy | From the end of radiotherapy (3 months) through 6 months post-radiotherapy | |
Secondary | Healthy margin resection rate (R0) | From the end of radiotherapy (3 months) through 6 months post-radiotherapy | ||
Secondary | Prognostic impact of CA 19-9 changes on survival | Through study completion, an average of 36 months | ||
Secondary | Quality of life by using the quality of life questionnaire score (QLQ-C30) | The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome. |
Through study completion, an average of 60 months | |
Secondary | Quality of life by using the quality of life questionnaire score (QLQ-PAN26) | The QLQ-PAN26 uses for the question 31 to 56 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). | Through study completion, an average of 60 months | |
Secondary | Assessment of adverse events by using the NCI-CTCAE version 5.0 scale | From inclusion of first patient until the end of treatment | Through study completion, an average of 36 months | |
Secondary | Correlation of planning target volume (PTV) coverage and dose received by the gross tumor volume (GTV) with progression free survival | End of radiotherapy | An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy) | |
Secondary | Correlation of planning target volume (PTV) coverage and dose received by the gross tumor volume (GTV) with overall survival | End of radiotherapy | An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy) | |
Secondary | Correlation of the dose received by organs at risk (duodenum, small intestine, stomach, colon) with the appearance of gastrointestinal toxicities | End of radiotherapy | An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy) | |
Secondary | Summation of the dosimetric results in terms of dose/volume for the adaptive radiotherapy sessions and comparison with the predicted dosimetry | End of radiotherapy | An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy) | |
Secondary | Coverage of the planning targeted volume (PTV) by the prescription dose | End of radiotherapy | An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy) | |
Secondary | Dose received by the gross total volume | End of radiotherapy | An average of 9 months after the beginning of treatment (chemotherapy then radiotherapy) | |
Secondary | Progression-free Survival (PFS) | Between the radiotherapy start date and the date of the first documented progression or the date of death from any cause | Through study completion, an average of 68 months | |
Secondary | Overall Survival (OS) | Interval between the radiotherapy start date and the date of death from any cause | Through study completion, an average of 72 months | |
Secondary | Local disease control | Interval between the radiotherapy start date and the date of local progression of the disease | Through study completion, an average of 68 months |
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