Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma: a prospective, phase II, multicentre, single-arm study

doi:10.1186/s12885-019-6108-0

Clinical Trial

. 2019 Sep 14;19(1):922.

doi: 10.1186/s12885-019-6108-0.

Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma: a prospective, phase II, multicentre, single-arm study

Viviana Vitolo¹, Lorenzo Cobianchi^{2

3}, Silvia Brugnatelli⁴, Amelia Barcellini⁵, Andrea Peloso^{6

7}, Angelica Facoetti¹, Alessandro Vanoli⁸, Sara Delfanti³, Lorenzo Preda^{1

3}, Silvia Molinelli¹, Catherine Klersy⁹, Piero Fossati^{1

10}, Roberto Orecchia^{1

11}, Francesca Valvo¹

Affiliations

¹ National Center of Oncological Hadrontherapy (Fondazione CNAO), Pavia, Italy.
² General Surgery Department, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
³ Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.
⁴ Department of Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
⁵ National Center of Oncological Hadrontherapy (Fondazione CNAO), Pavia, Italy. amelia.barcellini@cnao.it.
⁶ Hepatology and Transplantation Laboratory, Department of Surgery, Faculty of Medicine, University of Geneva, Geneva, Switzerland.
⁷ Divisions of Abdominal and Transplantation Surgery, Department of Surgery, Geneva University Hospitals, Geneva, Switzerland.
⁸ Anatomic Pathology Unit, Department of Molecular Medicine, University of Pavia and Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
⁹ Service of Clinical Epidemiology & Biometry, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
¹⁰ MedAustron Ion Therapy Center, Wiener Neustadt, Austria.
¹¹ European Institute of Oncology (IEO), Milan, Italy.

PMID: 31521134
PMCID: PMC6744648
DOI: 10.1186/s12885-019-6108-0

Clinical Trial

Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma: a prospective, phase II, multicentre, single-arm study

Viviana Vitolo et al. BMC Cancer. 2019.

. 2019 Sep 14;19(1):922.

doi: 10.1186/s12885-019-6108-0.

Authors

Affiliations

¹ National Center of Oncological Hadrontherapy (Fondazione CNAO), Pavia, Italy.
² General Surgery Department, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
³ Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.
⁴ Department of Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
⁵ National Center of Oncological Hadrontherapy (Fondazione CNAO), Pavia, Italy. amelia.barcellini@cnao.it.
⁶ Hepatology and Transplantation Laboratory, Department of Surgery, Faculty of Medicine, University of Geneva, Geneva, Switzerland.
⁷ Divisions of Abdominal and Transplantation Surgery, Department of Surgery, Geneva University Hospitals, Geneva, Switzerland.
⁸ Anatomic Pathology Unit, Department of Molecular Medicine, University of Pavia and Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
⁹ Service of Clinical Epidemiology & Biometry, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
¹⁰ MedAustron Ion Therapy Center, Wiener Neustadt, Austria.
¹¹ European Institute of Oncology (IEO), Milan, Italy.

PMID: 31521134
PMCID: PMC6744648
DOI: 10.1186/s12885-019-6108-0

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.

Keywords: Carbon ion radiation therapy; Chemotherapy; Pancreatic adenocarcinoma; Surgery.

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Conflict of interest statement

The authors declare that they have no competing interests.

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References

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1. Hackert T. Surgery for pancreatic Cancer after neoadjuvant treatment. Ann Gastroenterol Surg. 2018;2(6):413–418. doi: 10.1002/ags3.12203. - DOI - PMC - PubMed
1. McGuigan A, Kelly P, Turkington RC, Jones C, Coleman HG, McCain RS. Pancreatic cancer: a review of clinical diagnosis, epidemiology, treatment and outcomes. World J Gastroenterol. 2018;24(43):4846–4861. doi: 10.3748/wjg.v24.i43.4846. - DOI - PMC - PubMed
1. Zhan HX, Xu JW, Wu D, Wu ZY, Wang L, Hu SY, Zhang GY. Neoadjuvant therapy in pancreatic cancer: a systematic review and meta-analysis of prospective studies. Cancer Med. 2017;6(6):1201–1219. doi: 10.1002/cam4.1071. - DOI - PMC - PubMed
1. Reni M, Balzano G, Zanon S, Zerbi A, Rimassa L, Castoldi R, Pinelli D, Mosconi S, Doglioni C, Chiaravalli M, Pircher C, Arcidiacono PG, Torri V, Maggiora P, Ceraulo D, Falconi M, Gianni L. Safety and efficacy of preoperative or postoperative chemotherapy for resectable pancreatic adenocarcinoma (PACT-15): a randomised, open-label, phase 2-3 trial. Lancet Gastroenterol Hepatol. 2018;3(6):413–423. doi: 10.1016/S2468-1253(18)30081-5. - DOI - PubMed

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[1] Gillen S, Schuster T, Meyer Zum Buschenfelde C, Friess H, Kleeff J. Preoperative/neoadjuvant therapy in pancreatic cancer: a systematic review and meta-analysis of response and resection percentages. PLoS Med. 2010;7:e1000267. doi: 10.1371/journal.pmed.1000267. - DOI - PMC - PubMed

[2] Gillen S, Schuster T, Meyer Zum Buschenfelde C, Friess H, Kleeff J. Preoperative/neoadjuvant therapy in pancreatic cancer: a systematic review and meta-analysis of response and resection percentages. PLoS Med. 2010;7:e1000267. doi: 10.1371/journal.pmed.1000267. - DOI - PMC - PubMed

[3] Hackert T. Surgery for pancreatic Cancer after neoadjuvant treatment. Ann Gastroenterol Surg. 2018;2(6):413–418. doi: 10.1002/ags3.12203. - DOI - PMC - PubMed

[4] Hackert T. Surgery for pancreatic Cancer after neoadjuvant treatment. Ann Gastroenterol Surg. 2018;2(6):413–418. doi: 10.1002/ags3.12203. - DOI - PMC - PubMed

[5] McGuigan A, Kelly P, Turkington RC, Jones C, Coleman HG, McCain RS. Pancreatic cancer: a review of clinical diagnosis, epidemiology, treatment and outcomes. World J Gastroenterol. 2018;24(43):4846–4861. doi: 10.3748/wjg.v24.i43.4846. - DOI - PMC - PubMed

[6] McGuigan A, Kelly P, Turkington RC, Jones C, Coleman HG, McCain RS. Pancreatic cancer: a review of clinical diagnosis, epidemiology, treatment and outcomes. World J Gastroenterol. 2018;24(43):4846–4861. doi: 10.3748/wjg.v24.i43.4846. - DOI - PMC - PubMed

[7] Zhan HX, Xu JW, Wu D, Wu ZY, Wang L, Hu SY, Zhang GY. Neoadjuvant therapy in pancreatic cancer: a systematic review and meta-analysis of prospective studies. Cancer Med. 2017;6(6):1201–1219. doi: 10.1002/cam4.1071. - DOI - PMC - PubMed

[8] Zhan HX, Xu JW, Wu D, Wu ZY, Wang L, Hu SY, Zhang GY. Neoadjuvant therapy in pancreatic cancer: a systematic review and meta-analysis of prospective studies. Cancer Med. 2017;6(6):1201–1219. doi: 10.1002/cam4.1071. - DOI - PMC - PubMed

[9] Reni M, Balzano G, Zanon S, Zerbi A, Rimassa L, Castoldi R, Pinelli D, Mosconi S, Doglioni C, Chiaravalli M, Pircher C, Arcidiacono PG, Torri V, Maggiora P, Ceraulo D, Falconi M, Gianni L. Safety and efficacy of preoperative or postoperative chemotherapy for resectable pancreatic adenocarcinoma (PACT-15): a randomised, open-label, phase 2-3 trial. Lancet Gastroenterol Hepatol. 2018;3(6):413–423. doi: 10.1016/S2468-1253(18)30081-5. - DOI - PubMed

[10] Reni M, Balzano G, Zanon S, Zerbi A, Rimassa L, Castoldi R, Pinelli D, Mosconi S, Doglioni C, Chiaravalli M, Pircher C, Arcidiacono PG, Torri V, Maggiora P, Ceraulo D, Falconi M, Gianni L. Safety and efficacy of preoperative or postoperative chemotherapy for resectable pancreatic adenocarcinoma (PACT-15): a randomised, open-label, phase 2-3 trial. Lancet Gastroenterol Hepatol. 2018;3(6):413–423. doi: 10.1016/S2468-1253(18)30081-5. - DOI - PubMed

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Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma: a prospective, phase II, multicentre, single-arm study

Affiliations

Preoperative chemotherapy and carbon ions therapy for treatment of resectable and borderline resectable pancreatic adenocarcinoma: a prospective, phase II, multicentre, single-arm study

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Abstract

Conflict of interest statement

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