Durvalumab (MEDI 4736) in combination with extended neoadjuvant regimens in rectal cancer: a study protocol of a randomised phase II trial (PRIME-RT)

Catherine R. Hanna; Sean M. O’Cathail; Janet S. Graham; Mark Saunders; Leslie Samuel; Mark Harrison; Lynsey Devlin; Joanne Edwards; Daniel R. Gaya; Caroline A. Kelly; Liz-Anne Lewsley; Noori Maka; Paula Morrison; Louise Dinnett; Susan Dillon; Jacqueline Gourlay; Jonathan J. Platt; Fiona Thomson; Richard A. Adams; Campbell S. D. Roxburgh

doi:10.1186/s13014-021-01888-1

Durvalumab (MEDI 4736) in combination with extended neoadjuvant regimens in rectal cancer: a study protocol of a randomised phase II trial (PRIME-RT)

Catherine R. Hanna^* (Corresponding Author), Sean M. O’Cathail, Janet S. Graham, Mark Saunders, Leslie Samuel, Mark Harrison, Lynsey Devlin, Joanne Edwards, Daniel R. Gaya, Caroline A. Kelly, Liz-Anne Lewsley, Noori Maka, Paula Morrison, Louise Dinnett, Susan Dillon, Jacqueline Gourlay, Jonathan J. Platt, Fiona Thomson, Richard A. Adams, Campbell S. D. Roxburgh

^*Corresponding author for this work

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Abstract

Advances in multi-modality treatment of locally advanced rectal cancer (LARC) have resulted in low local recurrence rates, but around 30% of patients will still die from distant metastatic disease. In parallel, there is increasing recognition that with radiotherapy and systemic treatment, some patients achieve a complete response and may avoid surgical resection, including in many cases, the need for a permanent stoma. Extended neoadjuvant regimes have emerged to address these concerns. The inclusion of immunotherapy in the neoadjuvant setting has the potential to further enhance this strategy by priming the local immune microenvironment and engaging the systemic immune response.

Original language	English
Article number	163
Number of pages	9
Journal	Radiation Oncology
Volume	16
Issue number	1
DOIs	https://doi.org/10.1186/s13014-021-01888-1
Publication status	Published - 26 Aug 2021

Keywords

Rectal
neoplasm
chemotherapy
radiotherapy
immune-oncology
immunotherapy
clinical trial

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Hanna, C. R., O’Cathail, S. M., Graham, J. S., Saunders, M., Samuel, L., Harrison, M., Devlin, L., Edwards, J., Gaya, D. R., Kelly, C. A., Lewsley, L-A., Maka, N., Morrison, P., Dinnett, L., Dillon, S., Gourlay, J., Platt, J. J., Thomson, F., Adams, R. A., & Roxburgh, C. S. D. (2021). Durvalumab (MEDI 4736) in combination with extended neoadjuvant regimens in rectal cancer: a study protocol of a randomised phase II trial (PRIME-RT). Radiation Oncology, 16(1), [163]. https://doi.org/10.1186/s13014-021-01888-1

Hanna, CR, O’Cathail, SM, Graham, JS, Saunders, M, Samuel, L, Harrison, M, Devlin, L, Edwards, J, Gaya, DR, Kelly, CA, Lewsley, L-A, Maka, N, Morrison, P, Dinnett, L, Dillon, S, Gourlay, J, Platt, JJ, Thomson, F, Adams, RA & Roxburgh, CSD 2021, 'Durvalumab (MEDI 4736) in combination with extended neoadjuvant regimens in rectal cancer: a study protocol of a randomised phase II trial (PRIME-RT)', Radiation Oncology, vol. 16, no. 1, 163. https://doi.org/10.1186/s13014-021-01888-1

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title = "Durvalumab (MEDI 4736) in combination with extended neoadjuvant regimens in rectal cancer: a study protocol of a randomised phase II trial (PRIME-RT)",

abstract = "Advances in multi-modality treatment of locally advanced rectal cancer (LARC) have resulted in low local recurrence rates, but around 30% of patients will still die from distant metastatic disease. In parallel, there is increasing recognition that with radiotherapy and systemic treatment, some patients achieve a complete response and may avoid surgical resection, including in many cases, the need for a permanent stoma. Extended neoadjuvant regimes have emerged to address these concerns. The inclusion of immunotherapy in the neoadjuvant setting has the potential to further enhance this strategy by priming the local immune microenvironment and engaging the systemic immune response.",

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author = "Hanna, {Catherine R.} and O{\textquoteright}Cathail, {Sean M.} and Graham, {Janet S.} and Mark Saunders and Leslie Samuel and Mark Harrison and Lynsey Devlin and Joanne Edwards and Gaya, {Daniel R.} and Kelly, {Caroline A.} and Liz-Anne Lewsley and Noori Maka and Paula Morrison and Louise Dinnett and Susan Dillon and Jacqueline Gourlay and Platt, {Jonathan J.} and Fiona Thomson and Adams, {Richard A.} and Roxburgh, {Campbell S. D.}",

note = "Acknowledgements We are grateful to Mr George Davidson and Ms Monica Jeffers for their input with writing the PRIME-RT protocol and patient information sheet. This study is co-sponsored by the University of Glasgow and NHS Greater Glasgow and Clyde. Funding PRIME-RT is funded by Astrazeneca and receives core funding from CRUK Clinical Trials Unit Glasgow for the purposes of trial set-up and data collection. The trial is co-sponsored by the University Of Glasgow and NHS Greater Glasgow and Clyde.",

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AU - Saunders, Mark

AU - Samuel, Leslie

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AU - Maka, Noori

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AU - Roxburgh, Campbell S. D.

N1 - Acknowledgements We are grateful to Mr George Davidson and Ms Monica Jeffers for their input with writing the PRIME-RT protocol and patient information sheet. This study is co-sponsored by the University of Glasgow and NHS Greater Glasgow and Clyde. Funding PRIME-RT is funded by Astrazeneca and receives core funding from CRUK Clinical Trials Unit Glasgow for the purposes of trial set-up and data collection. The trial is co-sponsored by the University Of Glasgow and NHS Greater Glasgow and Clyde.

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AB - Advances in multi-modality treatment of locally advanced rectal cancer (LARC) have resulted in low local recurrence rates, but around 30% of patients will still die from distant metastatic disease. In parallel, there is increasing recognition that with radiotherapy and systemic treatment, some patients achieve a complete response and may avoid surgical resection, including in many cases, the need for a permanent stoma. Extended neoadjuvant regimes have emerged to address these concerns. The inclusion of immunotherapy in the neoadjuvant setting has the potential to further enhance this strategy by priming the local immune microenvironment and engaging the systemic immune response.

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KW - neoplasm

KW - chemotherapy

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KW - immune-oncology

KW - immunotherapy

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SN - 1748-717X

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M1 - 163

ER -

Durvalumab (MEDI 4736) in combination with extended neoadjuvant regimens in rectal cancer: a study protocol of a randomised phase II trial (PRIME-RT)

Abstract

Keywords

UN SDGs

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