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

Authors

null

Thomas Crosby

Velindre Hospital NHS Foundation Trust, Cardiff, United Kingdom

Thomas Crosby , Somnath Mukherjee , Chris Hurt , Sarah Gwynne , Simon Gollins , Andrew Rea Bateman , Wyn Griffith Lewis , Ganesh Radhakrishna , Maria Hawkins , Heike I. Grabsch , Ruby Ray , Ricky A. Sharma , Wendy Wade , Rhydian Maggs , Bethan Tranter , Ashley Roberts , Sue Hadlow , David Sebag-Montefiore , Tim Maughan , Gareth Griffiths

Organizations

Velindre Hospital NHS Foundation Trust, Cardiff, United Kingdom, Gray Institute for Radiation Oncology and Biology, University of Oxford, Oxford, United Kingdom, Cardiff University, Cardiff, United Kingdom, Swansea Hospital, Swansea, United Kingdom, North Wales Cancer Treatment Centre, Rhyl, United Kingdom, University of Southampton, Southampton, United Kingdom, University Hospital Wales, Cardiff, United Kingdom, St James University Hospital, West Yorkshire, United Kingdom, The Gray Institute for Radiation Oncology and Biology, Oxford, United Kingdom, Leeds Institute of Cancer Studies and Pathology, University of Leeds, Leeds, United Kingdom, Wales Cancer Trials Unit, Cardiff University, Cardiff, United Kingdom, NISCHR CRC South East Wales Research Network, Cardiff, United Kingdom, Cardiff NCRI RTTQA Group, Cardiff, United Kingdom, St James's Institute of Oncology, St. James's University Hospital, Leeds, United Kingdom

Research Funding

Other Foundation

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. Current Status: Activation: September 2013; Centres open: 10, in set-up:10; Recruitment: 13. Funding: Cancer Research UK. Sponsor: Velindre NHS Trust. Trials Unit: Wales Cancer Trials Unit. Eudract No: 2012-000640-10. Clinical trial information: NCT01843829.

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Abstract Details

Meeting

2014 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT01843829

Citation

J Clin Oncol 32:5s, 2014 (suppl; abstr TPS4144)

DOI

10.1200/jco.2014.32.15_suppl.tps4144

Abstract #

TPS4144

Poster Bd #

231A

Abstract Disclosures