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ICORG 10-14: NEOadjuvant trial in Adenocarcinoma of the oEsophagus and oesophagoGastric junction International Study (Neo-AEGIS)

ICORG 10-14: NEOadjuvant trial in Adenocarcinoma of the oEsophagus and oesophagoGastric junction International Study (Neo-AEGIS)
ICORG 10-14: NEOadjuvant trial in Adenocarcinoma of the oEsophagus and oesophagoGastric junction International Study (Neo-AEGIS)
Background:

Neoadjuvant therapy is increasingly the standard of care in the management of locally advanced adenocarcinoma of the oesophagus and junction (AEG). In randomised controlled trials (RCTs), the MAGIC regimen of pre- and postoperative chemotherapy, and the CROSS regimen of preoperative chemotherapy combined with radiation, were superior to surgery only in RCTs that included AEG but were not powered on this cohort. No completed RCT has directly compared neoadjuvant or perioperative chemotherapy and neoadjuvant chemoradiation. The Neo-AEGIS trial, uniquely powered on AEG, and including comprehensive modern staging, compares both these regimens.

Methods:

This open label, multicentre, phase III RCT randomises patients (cT2-3, N0-3, M0) in a 1:1 fashion to receive CROSS protocol (Carboplatin and Paclitaxel with concurrent radiotherapy, 41.4Gy/23Fr, over 5 weeks). The power calculation is a 10% difference in favour of CROSS, powered at 80%, two-sided alpha level of 0.05, requiring 540 patients to be evaluable, 594 to be recruited if a 10% dropout is included (297 in each group). The primary endpoint is overall survival, with a minimum 3-year follow up. Secondary endpoints include: disease free survival, recurrence rates, clinical and pathological response rates, toxicities of induction regimens, post-operative pathology and tumour regression grade, operative in-hospital complications, and health-related quality of life. The trial also affords opportunities for establishing a bio-resource of pre-treatment and resected tumour, and translational research.

Discussion:

This RCT directly compares two established treatment regimens, and addresses whether radiation therapy positively impacts on overall survival compared with a standard perioperative chemotherapy regimen Sponsor: Irish Clinical Research Group (ICORG).

Trial registration:

NCT01726452. Protocol 10-14. Date of registration 06/11/2012.
1471-2407
Reynolds, J.V.
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Preston, S.R.
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O’neill, B.
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Baeksgaard, L.
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Griffin, S.M.
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Mariette, C.
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Cuffe, S.
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Cunningham, M.
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Crosby, T.
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Parker, I.
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Hofland, K.
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Hanna, G.
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Svendsen, L.B.
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Donohoe, C.L.
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Muldoon, C.
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O’toole, D.
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Johnson, C.
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Jones, G.
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Corkhill, A.K.
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Illsley, M.
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Mellor, J.
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Lee, K.
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Dib, M.
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Marchesin, V.
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Scott, K.
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Lawner, P.
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Warren, S.
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O’Reilly, S.
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O’Dowd, G.
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Leonard, G.
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Hennessy, B.
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Mc Dermott, R.
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Reynolds, J.V.
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Preston, S.R.
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O’neill, B.
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Baeksgaard, L.
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Griffin, S.M.
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Mariette, C.
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Cuffe, S.
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Cunningham, M.
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Crosby, T.
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Parker, I.
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Hofland, K.
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Hanna, G.
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Svendsen, L.B.
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Donohoe, C.L.
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Muldoon, C.
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O’toole, D.
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Johnson, C.
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Ravi, N.
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Jones, G.
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Corkhill, A.K.
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Illsley, M.
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Mellor, J.
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Lee, K.
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Dib, M.
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Marchesin, V.
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Cunnane, M.
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Scott, K.
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Lawner, P.
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Warren, S.
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O’Reilly, S.
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O’Dowd, G.
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Leonard, G.
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Hennessy, B.
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Mc Dermott, R.
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Reynolds, J.V., Preston, S.R., O’neill, B., Baeksgaard, L., Griffin, S.M., Mariette, C., Cuffe, S., Cunningham, M., Crosby, T., Parker, I., Hofland, K., Hanna, G., Svendsen, L.B., Donohoe, C.L., Muldoon, C., O’toole, D., Johnson, C., Ravi, N., Jones, G., Corkhill, A.K., Illsley, M., Mellor, J., Lee, K., Dib, M., Marchesin, V., Cunnane, M., Scott, K., Lawner, P., Warren, S., O’Reilly, S., O’Dowd, G., Leonard, G., Hennessy, B. and Mc Dermott, R. (2017) ICORG 10-14: NEOadjuvant trial in Adenocarcinoma of the oEsophagus and oesophagoGastric junction International Study (Neo-AEGIS). BMC cancer, 17 (1). (doi:10.1186/s12885-017-3386-2).

Record type: Article

Abstract

Background:

Neoadjuvant therapy is increasingly the standard of care in the management of locally advanced adenocarcinoma of the oesophagus and junction (AEG). In randomised controlled trials (RCTs), the MAGIC regimen of pre- and postoperative chemotherapy, and the CROSS regimen of preoperative chemotherapy combined with radiation, were superior to surgery only in RCTs that included AEG but were not powered on this cohort. No completed RCT has directly compared neoadjuvant or perioperative chemotherapy and neoadjuvant chemoradiation. The Neo-AEGIS trial, uniquely powered on AEG, and including comprehensive modern staging, compares both these regimens.

Methods:

This open label, multicentre, phase III RCT randomises patients (cT2-3, N0-3, M0) in a 1:1 fashion to receive CROSS protocol (Carboplatin and Paclitaxel with concurrent radiotherapy, 41.4Gy/23Fr, over 5 weeks). The power calculation is a 10% difference in favour of CROSS, powered at 80%, two-sided alpha level of 0.05, requiring 540 patients to be evaluable, 594 to be recruited if a 10% dropout is included (297 in each group). The primary endpoint is overall survival, with a minimum 3-year follow up. Secondary endpoints include: disease free survival, recurrence rates, clinical and pathological response rates, toxicities of induction regimens, post-operative pathology and tumour regression grade, operative in-hospital complications, and health-related quality of life. The trial also affords opportunities for establishing a bio-resource of pre-treatment and resected tumour, and translational research.

Discussion:

This RCT directly compares two established treatment regimens, and addresses whether radiation therapy positively impacts on overall survival compared with a standard perioperative chemotherapy regimen Sponsor: Irish Clinical Research Group (ICORG).

Trial registration:

NCT01726452. Protocol 10-14. Date of registration 06/11/2012.

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Accepted/In Press date: 25 May 2017
e-pub ahead of print date: 3 June 2017

Identifiers

Local EPrints ID: 412341
URI: http://eprints.soton.ac.uk/id/eprint/412341
ISSN: 1471-2407
PURE UUID: 8552201c-a2e7-4702-80a8-85a7b77fb32c

Catalogue record

Date deposited: 17 Jul 2017 13:30
Last modified: 17 Jun 2024 16:33

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Contributors

Author: J.V. Reynolds
Author: S.R. Preston
Author: B. O’neill
Author: L. Baeksgaard
Author: S.M. Griffin
Author: C. Mariette
Author: S. Cuffe
Author: M. Cunningham
Author: T. Crosby
Author: I. Parker
Author: K. Hofland
Author: G. Hanna
Author: L.B. Svendsen
Author: C.L. Donohoe
Author: C. Muldoon
Author: D. O’toole
Author: C. Johnson
Author: N. Ravi
Author: G. Jones
Author: A.K. Corkhill
Author: M. Illsley
Author: J. Mellor
Author: K. Lee
Author: M. Dib
Author: V. Marchesin
Author: M. Cunnane
Author: K. Scott
Author: P. Lawner
Author: S. Warren
Author: S. O’Reilly
Author: G. O’Dowd
Author: G. Leonard
Author: B. Hennessy
Author: R. Mc Dermott

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