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The study was early closed due to low accrual in August 2022.
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| Name | Class |
|---|---|
| Fondazione IRCCS Policlinico San Matteo di Pavia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperatory chemoradiation therapy with carbon ions | Experimental | Chemoradiation followed by surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative chemotherapy | Drug | Preoperative chemotherapy, carbon ion therapy, surgery |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesca Valvo, MD | CNAO National Center of Oncological Hadrontherapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CNAO | Pavia | Pavia | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39462835 | Derived | Barcellini A, Molinelli S, Vanoli A, Vitolo V, Fossati P, Vai A, Pagani A, Inzani F, Pecorilla M, Butturini G, Klersy C, Preda L, Facoetti A, Valvo F, Orlandi E. Preoperative chemo-CIRT in Re/BRe pancreatic cancer: Insights from a multicenter prospective phase II clinical study (NCT03822936). Tumori. 2024 Dec;110(6):470-474. doi: 10.1177/03008916241291341. Epub 2024 Oct 27. | |
| 31521134 |
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The trial enrolls subjects that will receive in order: chemotherapy, carbon ion therapy, followed by surgical resection after 4/6 weeks then adjuvant chemotherapy.
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| Preoperative radiotherapy | Radiation | Preoperative chemotherapy, carbon ion therapy, surgery |
|
|
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 |
| Derived |
| Vitolo V, Cobianchi L, Brugnatelli S, Barcellini A, Peloso A, Facoetti A, Vanoli A, Delfanti S, Preda L, Molinelli S, Klersy C, Fossati P, Orecchia R, Valvo F. Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma: a prospective, phase II, multicentre, single-arm study. BMC Cancer. 2019 Sep 14;19(1):922. doi: 10.1186/s12885-019-6108-0. |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D002955 | Leucovorin |
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| D063193 | Heavy Ion Radiotherapy |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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