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PHASE II study evaluating the benefit of Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515344-23-00
Acronym
PROICM 2020-04 GAB
Enrollment
103
Registered
2024-08-12
Start date
2021-06-17
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

local advenced pancreatic adenocarcinoma

Brief summary

1: Non-progression rate at 4 months (SEQ1 success rate) according to RECIST 1.1 criteria 2: Rate of RT-related acute digestive non-toxicity within 90d of grade ≥3 assessed by NCI CTC AE v5.0 classification

Detailed description

Tolerance of chemotherapy sequence assessed by NCI CTC AE v5.0 classification, Tolerance (acute and delayed toxicities) of radiotherapy sequence assessed by NCI CTC AE v5.0 classification, 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....), Collection and summation of 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) with the occurrence of digestive toxicities (predictive and adaptive dosimetry), Correlation of PTV coverage and GTV dose with progression-free survival and overall survival (predictive and adaptive dosimetry), 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., Overall survival defined as time from radiotherapy start date to date of death from any cause., 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, Progression-free survival defined as time from inclusion to date of 1st documented progression or date of death from any cause., Overall survival defined as time from date of inclusion to date of death from any cause., Tolerance of overall treatment assessed by NCI CTC AE v5.0 classification., Resection rate defined as the percentage of patients operated on up to 6 months post-radiotherapy., R0 resection rate, Histological response rate* according to CAP score30, 31, 32, Assess the prognostic impact of CA 19.9 evolution on survival, Evolution of Quality of Life scores assessed by the EORTC QLQ-C30 and PAN 26 questionnaires.

Interventions

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.
DRUGsolution à diluer pour perfusion
DRUGLEVOFOLINATE DE CALCIUM ZENTIVA 25 mg/2
DRUG5ml

Sponsors

Institut Regional Du Cancer De Montpellier
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1: Non-progression rate at 4 months (SEQ1 success rate) according to RECIST 1.1 criteria 2: Rate of RT-related acute digestive non-toxicity within 90d of grade ≥3 assessed by NCI CTC AE v5.0 classification

Secondary

MeasureTime frame
Tolerance of chemotherapy sequence assessed by NCI CTC AE v5.0 classification, Tolerance (acute and delayed toxicities) of radiotherapy sequence assessed by NCI CTC AE v5.0 classification, 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....), Collection and summation of 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) with the occurrence of digestive toxicities (predictive and adaptive dosimetry), Correlation of PTV coverage and GTV dose with progression-free survival and overall survival (predictive and adaptive dosimetry), 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

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026