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2018-02-08
2022-08-08
2025-02-10
30
NCT03822936
CNAO National Center of Oncological Hadrontherapy
CNAO National Center of Oncological Hadrontherapy
INTERVENTIONAL
Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma
Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-01-25 | N/A | 2025-02-11 |
2019-01-28 | N/A | 2025-02-13 |
2019-01-30 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Preoperatory chemoradiation therapy with carbon ions Chemoradiation followed by surgery | DRUG: Preoperative chemotherapy
RADIATION: Preoperative radiotherapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression free survival | The local progression free survival is measured | The local progression free survival will be assessed at 1-year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| overall survival | the overall survival of enrolled patients is considered | The overall survival of enrolled patients will be assessed at 2-years |
| resectability rate R0 stratified (operable vs not operable) | how many surgeries completed according to the procedures and with histopathological margins free from the disease/enrolled patients | time of surgery (4-6 weeks after radiotherapy) |
| Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity | Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity | The incidence of acute and medium term toxicity will be assessed up to 90 and 180 post-operative days respectively. The incidence of late toxicity will be assessed through study completion, an average of 1 year. |
| intra and perioperatory complications | intra and perioperatory complications | The incidence of intra- and perioperatory complications will be assessed up to 30 post-operative days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
