Cardiff University | Prifysgol Caerdydd ORCA
Online Research @ Cardiff 
WelshClear Cookie - decide language by browser settings

NeoSCOPE: A phase II randomized comparison of neoadjuvant oxaliplatin/capecitabine versus carboplatin/paclitaxel-based chemoradiation in operable esophageal cancer [Abstract]

Crosby, Thomas, Mukherjee, Somnath, Hurt, Chris Nicholas ORCID: https://orcid.org/0000-0003-1206-8355, Gwynne, Sarah, Gollins, Simon, Batrman, Andrew Rea, Lewis, Wyn Griffith, Radhakrishna, Ganesh, Hawkins, Maria, Grabsch, Heike I., Ray, Ruby, Sharma, Ricky A., Wade, Wendy, Maggs, Rhydian, Tranter, Bethan, Roberts, Ashley, Hadlow, Sue, Sebag-Montefiore, David, Maughan, Tim and Griffiths, Gareth 2014. NeoSCOPE: A phase II randomized comparison of neoadjuvant oxaliplatin/capecitabine versus carboplatin/paclitaxel-based chemoradiation in operable esophageal cancer [Abstract]. Journal of Clinical Oncology 32 (15_sup) , TPS4144. 10.1200/jco.2014.32.15_suppl.tps4144

Full text not available from this repository.

Abstract

Background: Both oxaliplatin/capecitabine-based chemoradiation (OXCAP-RT) and carboplatin-paclitaxel based radiation (CarPac-RT) are active regimens in oesophageal cancer, but no randomized study has compared their efficacy/toxicity. This study compares the two regimens to identify the optimum regimen to take forward to a phase III trial against neo-adjuvant chemotherapy, the current standard in the UK. Methods: Eligibility: Resectable adenocarcinoma of oesophagus and Type 1-2 Gastro-Osophageal Junction; ≥T3 and/or ≥N1 staged with EUS and PET-CT; PS 0-1. Intervention: Both arms receive 2 cycles induction OXCAP (oxaliplatin 130mg/m2 D1, Cape 625mg/m2 D1-21, q 3wk) followed by randomization to OXCAP-RT (oxali 85mg/m2 Day 1,15,29; cape 625mg/m2 on days of RT; RT-45Gy/25 fractions/5weeks) or CarPac-RT (Carbo AUC2 and paclitaxel 50mg/m2 Day 1,8,15,22,29; RT-45Gy/25 fractions/5weeks). Restaging CT/PET-CT 4-6 weeks after CRT, and 2-phase oesophagectomy with 2-field lymphadenectomy 6-8 weeks after CRT. Primary End-Point: Pathological complete response. Secondary: 1) Feasibility of recruitment; Toxicity; 30-day surgical morbidity/mortality; resection margin positivity rate; median, 3- and 5-yr OS. Statistics: Randomised phase II with 1:1 randomisation; planned accrual 76 patients (38/arm) over 18 months. In each arm, this sample size gives 90% power and one-sided type 1 error of 10% to detect that pCR is not <15% but could be >35%. Interim safety analysis: Toxicity analysis after 10 patients have completed treatment. RT Quality Assurance: Pre-trial: Detailed RT protocol and guidance document, RT workshop, central evaluation of test-case contours and adequacy of RT plan. On-trial: Real-time central review of contours and plans of first 20 patients on trial, 1st case from each centre, and 10% of cases selected at random.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Subjects: R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Publisher: American Society of Clinical Oncology
ISSN: 1527-7755
Last Modified: 04 Mar 2023 02:15
URI: https://orca.cardiff.ac.uk/id/eprint/90212

Actions (repository staff only)

Edit Item Edit Item