TY - JOUR

T1 - ICORG 10-14

T2 - NEOadjuvant trial in Adenocarcinoma of the oEsophagus and oesophagoGastric junction International Study (Neo-AEGIS)

AU - Reynolds, J V

AU - Preston, S R

AU - O'Neill, B

AU - Baeksgaard, L

AU - Griffin, S M

AU - Mariette, C

AU - Cuffe, S

AU - Cunningham, M

AU - Crosby, T

AU - Parker, I

AU - Hofland, K

AU - Hanna, G

AU - Svendsen, L B

AU - Donohoe, C L

AU - Muldoon, C

AU - O'Toole, D

AU - Johnson, C

AU - Ravi, N

AU - Jones, G

AU - Corkhill, A K

AU - Illsley, M

AU - Mellor, J

AU - Lee, K

AU - Dib, M

AU - Marchesin, V

AU - Cunnane, M

AU - Scott, K

AU - Lawner, P

AU - Warren, S

AU - O'Reilly, S

AU - O'Dowd, G

AU - Leonard, G

AU - Hennessy, B

AU - Dermott, R Mc

PY - 2017/6/3

Y1 - 2017/6/3

N2 - 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.

AB - 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.

KW - Adenocarcinoma/drug therapy

KW - Adult

KW - Aged

KW - Antineoplastic Combined Chemotherapy Protocols/administration & dosage

KW - Carboplatin/administration & dosage

KW - Disease-Free Survival

KW - Esophageal Neoplasms/drug therapy

KW - Esophagogastric Junction/drug effects

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Neoadjuvant Therapy

KW - Neoplasm Recurrence, Local/drug therapy

KW - Paclitaxel/administration & dosage

KW - Quality of Life

U2 - 10.1186/s12885-017-3386-2

DO - 10.1186/s12885-017-3386-2

M3 - Journal article

C2 - 28578652

VL - 17

JO - B M C Cancer

JF - B M C Cancer

SN - 1471-2407

M1 - 401

ER -