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, 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 Jun 2019 13:34
URI: http://orca.cf.ac.uk/id/eprint/90212

Actions (repository staff only)

Edit Item Edit Item