Abstract
Background: Pancreatic adenocarcinoma is a high-mortality neoplasm with a documented 5-years-overall survival around 5%. In the last decades, a real breakthrough in the treatment of the disease has not been achieved. Here we propose a prospective, phase II, multicentre, single-arm study aiming to assess the efficacy and the feasibility of a therapeutic protocol combining chemotherapy, carbon ion therapy and surgery for resectable and borderline resectable pancreatic adenocarcinoma. Method: The purpose of this trial (PIOPPO Protocol) is to assess the efficacy and the feasibility of 3 cycles of FOLFIRINOX neoadjuvant chemotherapy followed by a short-course of carbon ion radiotherapy (CIRT) for resectable or borderline resectable pancreatic adenocarcinoma patients. Primary outcome of this study is the assessment of local progression free survival (L-PFS). The calculation of sample size is based on the analysis of the primary endpoint "progression free survival" according to Fleming's Procedure. Discussion: Very preliminary results provide initial evidence of the feasibility of the combined chemotherapy and CIRT in the neoadjuvant setting for resectable or borderline resectable pancreatic cancer. Completion of the accrual and long term results are awaited to see if this combination of treatment is advisable and will provide the expected benefits. Trial registration: ClinicalTrials.gov Identifier: NCT03822936 registered on January 2019.
| Original language | English |
|---|---|
| Article number | 922 |
| Journal | BMC Cancer |
| Volume | 19 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Sep 14 2019 |
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Keywords
- Carbon ion radiation therapy
- Chemotherapy
- Pancreatic adenocarcinoma
- Surgery
ASJC Scopus subject areas
- Oncology
- Genetics
- Cancer Research
Cite this
Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma : A prospective, phase II, multicentre, single-arm study. / Vitolo, Viviana; Cobianchi, Lorenzo; Brugnatelli, Silvia; Barcellini, Amelia; Peloso, Andrea; Facoetti, Angelica; Vanoli, Alessandro; Delfanti, Sara; Preda, Lorenzo; Molinelli, Silvia; Klersy, Catherine; Fossati, Piero; Orecchia, Roberto; Valvo, Francesca.
In: BMC Cancer, Vol. 19, No. 1, 922, 14.09.2019.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma
T2 - A prospective, phase II, multicentre, single-arm study
AU - Vitolo, Viviana
AU - Cobianchi, Lorenzo
AU - Brugnatelli, Silvia
AU - Barcellini, Amelia
AU - Peloso, Andrea
AU - Facoetti, Angelica
AU - Vanoli, Alessandro
AU - Delfanti, Sara
AU - Preda, Lorenzo
AU - Molinelli, Silvia
AU - Klersy, Catherine
AU - Fossati, Piero
AU - Orecchia, Roberto
AU - Valvo, Francesca
PY - 2019/9/14
Y1 - 2019/9/14
N2 - Background: Pancreatic adenocarcinoma is a high-mortality neoplasm with a documented 5-years-overall survival around 5%. In the last decades, a real breakthrough in the treatment of the disease has not been achieved. Here we propose a prospective, phase II, multicentre, single-arm study aiming to assess the efficacy and the feasibility of a therapeutic protocol combining chemotherapy, carbon ion therapy and surgery for resectable and borderline resectable pancreatic adenocarcinoma. Method: The purpose of this trial (PIOPPO Protocol) is to assess the efficacy and the feasibility of 3 cycles of FOLFIRINOX neoadjuvant chemotherapy followed by a short-course of carbon ion radiotherapy (CIRT) for resectable or borderline resectable pancreatic adenocarcinoma patients. Primary outcome of this study is the assessment of local progression free survival (L-PFS). The calculation of sample size is based on the analysis of the primary endpoint "progression free survival" according to Fleming's Procedure. Discussion: Very preliminary results provide initial evidence of the feasibility of the combined chemotherapy and CIRT in the neoadjuvant setting for resectable or borderline resectable pancreatic cancer. Completion of the accrual and long term results are awaited to see if this combination of treatment is advisable and will provide the expected benefits. Trial registration: ClinicalTrials.gov Identifier: NCT03822936 registered on January 2019.
AB - Background: Pancreatic adenocarcinoma is a high-mortality neoplasm with a documented 5-years-overall survival around 5%. In the last decades, a real breakthrough in the treatment of the disease has not been achieved. Here we propose a prospective, phase II, multicentre, single-arm study aiming to assess the efficacy and the feasibility of a therapeutic protocol combining chemotherapy, carbon ion therapy and surgery for resectable and borderline resectable pancreatic adenocarcinoma. Method: The purpose of this trial (PIOPPO Protocol) is to assess the efficacy and the feasibility of 3 cycles of FOLFIRINOX neoadjuvant chemotherapy followed by a short-course of carbon ion radiotherapy (CIRT) for resectable or borderline resectable pancreatic adenocarcinoma patients. Primary outcome of this study is the assessment of local progression free survival (L-PFS). The calculation of sample size is based on the analysis of the primary endpoint "progression free survival" according to Fleming's Procedure. Discussion: Very preliminary results provide initial evidence of the feasibility of the combined chemotherapy and CIRT in the neoadjuvant setting for resectable or borderline resectable pancreatic cancer. Completion of the accrual and long term results are awaited to see if this combination of treatment is advisable and will provide the expected benefits. Trial registration: ClinicalTrials.gov Identifier: NCT03822936 registered on January 2019.
KW - Carbon ion radiation therapy
KW - Chemotherapy
KW - Pancreatic adenocarcinoma
KW - Surgery
UR - http://www.scopus.com/inward/record.url?scp=85072174155&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85072174155&partnerID=8YFLogxK
U2 - 10.1186/s12885-019-6108-0
DO - 10.1186/s12885-019-6108-0
M3 - Article
C2 - 31521134
AN - SCOPUS:85072174155
VL - 19
JO - BMC Cancer
JF - BMC Cancer
SN - 1471-2407
IS - 1
M1 - 922
ER -