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Neoadjuvant Chemoradiotherapy and Surgery Versus Surgery Alone in Resectable Pancreatic Cancer: A Single-Center Prospective, Randomized, Controlled Trial Which Failed to Achieve Accrual Targets

  • Original Article
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Journal of Gastrointestinal Surgery Aims and scope

Abstract

Objective

The objective of the study is to evaluate the usefulness of neoadjuvant chemoradiotherapy in resectable pancreatic cancer.

Methods

A single-center RCT of patients affected by resectable pancreatic adenocarcinoma which included arm A (surgery alone) and arm B (neoadjuvant chemoradiation and surgery). The primary endpoint was R0 resection; the secondary endpoints were toxicity; number of patients who completed the neoadjuvant therapy; radiological and pathological response after chemoradiation; and pTNM stage, postoperative morbidity, mortality, and overall and disease-free survival. A sample size of 32 patients was required for each group.

Results

The study was terminated early, and 38 patients were randomized: 20 in arm A and 18 in arm B. There was no significant difference regarding R0 resection rate in the two groups (intention-to-treat, OR = 1.91, P = 0.489). Neoadjuvant chemoradiotherapy was completed in 14 out of 18 cases (77.8 %) and the radiological and pathological response was efficacious in 72.3 and 90.9 % of cases, respectively.

Conclusions

Neoadjuvant chemoradiation was feasible, safe, and efficacious, although non-significant results were obtained as a result of the underpowered data due to the difficulty in recruiting patients. Additional multicenter RCTs are needed in the future.

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Acknowledgments

We are grateful to the patients who participated in this study. We thank Prof. Roberto Corinaldesi (Bologna, Italy) who coordinated the study and Nicola Zanini and Giovanni Taffurelli, medical doctors, who helped us to recruit the patients.

Disclosure

No commercial interest, financial source, or material support to disclose.

Conflict of Interest

The authors declare that they have no competing interest.

Author information

Authors and Affiliations

  1. Dipartimento di Scienze Mediche e Chirurgiche (DIMEC), Chirurgia Generale-Minni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy

    Riccardo Casadei, Claudio Ricci, Marielda D’Ambra, Antonio Maria Morselli-Labate & Francesco Minni

  2. Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale (DIMES), Oncologia Medica-Biasco, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy

    Mariacristina Di Marco

  3. Anatomia Patologica-Grigioni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy

    Donatella Santini

  4. Medicina Interna-Morelli, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy

    Carla Serra

  5. Radiologia-Zompatori, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy

    Lucia Calculli

  6. Radioterapia-Zompatori, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy

    Alessandra Guido

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  1. Riccardo Casadei
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Correspondence to Riccardo Casadei.

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Casadei, R., Di Marco, M., Ricci, C. et al. Neoadjuvant Chemoradiotherapy and Surgery Versus Surgery Alone in Resectable Pancreatic Cancer: A Single-Center Prospective, Randomized, Controlled Trial Which Failed to Achieve Accrual Targets. J Gastrointest Surg 19, 1802–1812 (2015). https://doi.org/10.1007/s11605-015-2890-4

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