Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma (PIOPPO)
Phase II Clinical Study on Resectable or Borderline Resectable Pancreas Adenocarcinoma Preoperative Treatment with Chemotherapy and Carbon Ions Radiation Therapy (hadrontherapy)
Sponsor: CNAO National Center of Oncological Hadrontherapy
Terminated
The study was early closed due to low accrual in August 2022.
This PHASE2 trial investigates Cancer of Pancreas and Pancreas Adenocarcinoma and is currently terminated or withdrawn. CNAO National Center of Oncological Hadrontherapy leads this study, which shows 10 recorded versions since 2018 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)Enrolled subjects will undergo to 3 cycles of Folfirinox before re-evaluation of the lesion. Then, 4D planning and imaging with respiratory gating end rescanning technique will be adopted to calculate the optimal treatment plan to carbon ions radiation therapy: 38.4 Gy\[RBE\] is the prescribed dose to CTV. 4.8 Gy\[RBE\]/fraction will be delivered 4 times a week in two weeks. 4/6 weeks after hadrontherapy, after a CT scan with contrast, patient will undergo to a surgery. After 4/6 weeks, Gemcitabine will be administered for 6 cycles.
Secondary endpoints of the trial are overall survival, resectability rate (operable vs borderline operable), acute toxicity within 3 months, 3-6 months, over 6 months.
Enrolled subjects will undergo to 3 cycles of Folfirinox before re-evaluation of the lesion. Then, 4D planning and imaging with respiratory gating end rescanning technique will be adopted to calculate the optimal treatment plan to carbon ions radiation therapy: 38.4 Gy\[RBE\] is the prescribed dose to CTV. 4.8 Gy\[RBE\]/fraction will be delivered 4 times a week in two weeks. 4/6 weeks after hadrontherapy, after a CT scan with contrast, patient will undergo to a surgery. After 4/6 weeks, Gemcitabine will be administered for 6 cycles.
Secondary endpoints of the trial are overall survival, resectability rate (operable vs borderline operable), acute toxicity within 3 months, 3-6 months, over 6 months.
Status Flow
Change History
10 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE2
-
Mar 2025 — Present [monthly]
Terminated PHASE2
Status: Unknown → Terminated
-
Sep 2024 — Mar 2025 [monthly]
Unknown PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE2
Status: Unknown Status → Unknown
-
Sep 2023 — Jul 2024 [monthly]
Unknown Status PHASE2
Status: Recruiting → Unknown Status
▶ Show 5 earlier versions
-
Oct 2021 — Sep 2023 [monthly]
Recruiting PHASE2
-
Jan 2021 — Oct 2021 [monthly]
Recruiting PHASE2
-
Aug 2020 — Jan 2021 [monthly]
Recruiting PHASE2
-
Mar 2019 — Aug 2020 [monthly]
Recruiting PHASE2
-
Feb 2019 — Mar 2019 [monthly]
Recruiting PHASE2
First recorded
Feb 2018
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- CNAO National Center of Oncological Hadrontherapy
- Fondazione IRCCS Policlinico San Matteo di Pavia
For direct contact, visit the study record on ClinicalTrials.gov .