PACLITAXEL ALBUMIN-BOUND for Locally advanced pancreatic adenocarcinoma

Inclusion criteria

• {"criterion_text":"- Patient between 18 and 75 years of age on the date of signing the consent form"}
• {"criterion_text":"- Histologically or cytologically proven pancreatic adenocarcinoma."}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 1"}
• {"criterion_text":"- Non-resectability criteria, according to NCCN 1.2015 recommendations (Appendix 14) validated during centralized review."}
• {"criterion_text":"- Non-metastatic patient confirmed by TAP scan and liver MRI"}
• {"criterion_text":"- Feasibility of MRI-guided radiotherapy confirmed by centralized review"}
• {"criterion_text":"- 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

• {"criterion_text":"- Any previous treatment for pancreatic cancer (chemotherapy, radiotherapy, surgery, targeted therapy or experimental therapy, etc.)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- History of radiotherapy leading to a foreseeable overlap with the radiotherapy treatment under study (history of abdominal irradiation)"}
• {"criterion_text":"- Peripheral neuropathy ≥ grade 2"}
• {"criterion_text":"- ECG with QTc interval greater than 450 ms for men and greater than 470 ms for women"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Brivudine-based treatment within 4 weeks before or after 5-fluorouracil treatment (potentially fatal interaction)."}
• {"criterion_text":"- Patient having received a live attenuated vaccine within 10 days prior to inclusion and up to 6 months following cessation of chemotherapy."}

Primary endpoints

• {"endpoint_text":"- 1: Non-progression rate at 4 months (SEQ1 success rate) according to RECIST 1.1 criteria","definition_or_measurement_approach":"Measured according to RECIST 1.1 criteria; non-progression rate at 4 months after start of sequence 1."}
• {"endpoint_text":"- 2: Rate of RT-related acute digestive non-toxicity within 90d of grade ≥3 assessed by NCI CTC AE v5.0 classification","definition_or_measurement_approach":"Acute digestive toxicity related to radiotherapy within 90 days, graded by NCI CTCAE v5.0; rate of grade ≥3 events recorded."}

Secondary endpoints

• {"endpoint_text":"- Tolerance of chemotherapy sequence assessed by NCI CTC AE v5.0 classification","definition_or_measurement_approach":"Chemotherapy tolerability assessed and graded using NCI CTCAE v5.0."}
• {"endpoint_text":"- Tolerance (acute and delayed toxicities) of radiotherapy sequence assessed by NCI CTC AE v5.0 classification","definition_or_measurement_approach":"Radiotherapy-related acute and delayed toxicities assessed using NCI CTCAE v5.0."}
• {"endpoint_text":"- Collection of dosimetric results obtained in terms of dose/volume on predictive dosimetry (PTV coverage by prescription dose on totalized dosimetry, dose received at GTV....)","definition_or_measurement_approach":"Collection of predictive dosimetry dose/volume metrics including PTV coverage and GTV dose."}
• {"endpoint_text":"- Collection and summation of dosimetric results obtained in terms of dose/volume for adaptive radiotherapy sessions, and comparison with predictive dosimetry.","definition_or_measurement_approach":"Collect and sum adaptive session dosimetric dose/volume results and compare with predictive dosimetry metrics."}
• {"endpoint_text":"- Correlation of dose to organs at risk (duodenum, small intestine, stomach, colon) with the occurrence of digestive toxicities (predictive and adaptive dosimetry)","definition_or_measurement_approach":"Correlation analysis between organ-at-risk dose metrics (duodenum, small intestine, stomach, colon) and observed digestive toxicities using predictive and adaptive dosimetry."}
• {"endpoint_text":"- Correlation of PTV coverage and GTV dose with progression-free survival and overall survival (predictive and adaptive dosimetry)","definition_or_measurement_approach":"Correlation analysis between PTV coverage/GTV dose and progression-free survival and overall survival using predictive and adaptive dosimetry parameters."}
• {"endpoint_text":"- Progression-free survival defined as time from radiotherapy start date to date of 1st documented progression or date of death from any cause. - Overall survival defined as time from radiotherapy start date to date of death from any cause.","definition_or_measurement_approach":"PFS: time from radiotherapy start to first documented progression or death; OS: time from radiotherapy start to death from any cause."}
• {"endpoint_text":"- Overall survival defined as time from radiotherapy start date to date of death from any cause.","definition_or_measurement_approach":"Overall survival measured from radiotherapy start date to date of death from any cause."}
• {"endpoint_text":"- Local disease control rate defined as the proportion of patients without local progression, with time to local progression defined as the time from radiotherapy start date to the date of documented local progression. Patients without local progression will be censored at the date of last news","definition_or_measurement_approach":"Local control rate = proportion without local progression; time to local progression measured from radiotherapy start to documented local progression; censoring at last contact for those without local progression."}
• {"endpoint_text":"- Progression-free survival defined as time from inclusion to date of 1st documented progression or date of death from any cause.","definition_or_measurement_approach":"PFS measured from inclusion to first documented progression or death from any cause."}
• {"endpoint_text":"- Overall survival defined as time from date of inclusion to date of death from any cause.","definition_or_measurement_approach":"OS measured from inclusion date to date of death from any cause."}
• {"endpoint_text":"- Tolerance of overall treatment assessed by NCI CTC AE v5.0 classification.","definition_or_measurement_approach":"Overall treatment tolerability graded using NCI CTCAE v5.0."}
• {"endpoint_text":"- Resection rate defined as the percentage of patients operated on up to 6 months post-radiotherapy.","definition_or_measurement_approach":"Resection rate = percentage of patients undergoing surgery within 6 months after radiotherapy."}
• {"endpoint_text":"- R0 resection rate","definition_or_measurement_approach":"Proportion of resections achieving R0 margins among operated patients."}
• {"endpoint_text":"- Histological response rate* according to CAP score30, 31, 32","definition_or_measurement_approach":"Histological response assessed by CAP scoring system."}
• {"endpoint_text":"- Assess the prognostic impact of CA 19.9 evolution on survival","definition_or_measurement_approach":"Analysis of CA 19.9 marker evolution and its prognostic correlation with survival outcomes."}
• {"endpoint_text":"- Evolution of Quality of Life scores assessed by the EORTC QLQ-C30 and PAN 26 questionnaires.","definition_or_measurement_approach":"Quality of life measured serially using EORTC QLQ-C30 and PAN26 questionnaires; change over time evaluated."}

France

Earliest CTIS Part Ii Submission Date

11-07-2024

Latest Decision Or Authorization Date

24-03-2025

Processing Time Days

256

Number Of Sites

13

Number Of Participants

103

Primary sponsor

Full Name

Institut Regional Du Cancer De Montpellier

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France