NEOSCOPE: A randomised Phase II study of induction chemotherapy followed by either oxaliplatin/capecitabine (OXCAP) or carboplatin/paclitaxel (CarPac) based chemoradiation (CRT) as pre-operative regimen for resectable oesophageal adenocarcinoma.

Authors

null

Somnath Mukherjee

University of Oxford, Oxford, United Kingdom

Somnath Mukherjee , Chris Hurt , Sarah Gwynne , Andrew Bateman , Simon Gollins , Ganesh Radhakrishna , Jo Canham , Ruby Ray , Heike I Grabsch , Ricky A. Sharma , Rhydian Maggs , Maria A Hawkins , David Sebag-Montefiore , Tim Maughan , Gareth Griffiths , Tom David Lewis Crosby

Organizations

University of Oxford, Oxford, United Kingdom, Cardiff University, Cardiff, United Kingdom, Swansea Hospital, Swansea, United Kingdom, University of Southampton School of Medicine, Southampton, United Kingdom, North Wales Cancer Treatment Centre, Rhyl, United Kingdom, Leeds Teaching Hospitals NHS trust, Leeds, United Kingdom, Wales Cancer Trials Unit, Cardiff University, Cardiff, United Kingdom, Maastricht University Medical Centre, Maastricht, Netherlands, Gray Institute for Radiation Oncology and Biology, University of Oxford, Oxford, United Kingdom, Cardiff NCRI RTTQA Group, Cardiff, United Kingdom, St. James's Institute of Oncology, St. James's University Hospital, Leeds, United Kingdom, University of Southampton, Southampton, United Kingdom, Velindre Cancer Centre, Cardiff, United Kingdom

Research Funding

Other

Background: NEOSCOPE compared toxicity and efficacy of 2 pre-op CRT regimens. Methods: Eligibility: Resectable ACA of the oesophagus/GOJ ≥ T3 and/or ≥ N1. Randomisation: 1:1 to OXCAP-CRT (oxaliplatin 85 mg/m2 Day 1,15,29; capecitabine 625 mg/m2 bd on days of RT) or CarPac-CRT (Carboplatin AUC2; paclitaxel 50 mg/m2 Day 1,8,15,22,29); concurrent RT: 45Gy/25 fractions/5 weeks. Both arms received induction chemo: 2 cycles of OXCAP (oxaliplatin 130 mg/m2 D1, Cape 625 mg/m2D1-21, q 3wk). Surgery: 6-8 weeks after naCRT. Detailed RT and pathology quality assurance was built into the protocol. Primary end-point: pathological complete response (pCR). Secondary: toxicity, surgical morbidity/mortality, R1 rate, OS. Statistics: A pCR of 15% would not warrant further investigation but a pCR of 35% would. 76 patients (38/arm) gave 90% power and one-sided type I error of 10% meaning that either arm having ≥10 pCR out of first 38 patients would be considered for Phase III. 85 patients to be recruited (allows 10% loss to follow up). Results: 85 patients were randomised between Oct 2013 and Feb 2015 from 17 UK centres. Patient characteristics: median age 65 yrs, Male (81%), WHO PS 0 (85%). Tumour characteristics: T3 (86%), N1 (48%), lower third/GOJ (90%), median tumour length 5.8cm. CTCAE grade 3/4 toxicity rate during CRT was OXCAP-CRT 42.1%, CarPac-CRT 52.4% (p=0.358). Protocol dose RT OXCAP-CRT 90.5%, CarPac-CRT 93%. Conclusion:Both regimens were well tolerated. CarPac-CRT passed the criteria for taking forward to a phase III study but OXCAP-RT did not. Funding: Cancer Research UK (C44694/A14614), ClinicalTrials.gov: NCT01843829, coordinated by Wales Cancer Trials Unit. Clinical trial information: NCT01843829

OXCAP-CRTCarPac-CRT
Randomised4243
No surgery62
Died31
Progression21
Comorbidity10
Had surgery3641
pCR512*
pCR % (all patients)11.9%27.9%
pCR % (resected patients)13.9%29.3%
R02633
30 day post-op mortality11
30 day post-op complication19 (52.8%)21 (51.2%)
Anastomotic leak (none/present/missing)32/0/435/3/3

*10 out of first 38 patients randomised to this arm.

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Abstract Details

Meeting

2016 Gastrointestinal Cancers Symposium

Session Type

Oral Abstract Session

Session Title

Oral Abstract Session: Cancers of the Esophagus and Stomach

Track

Cancers of the Esophagus and Stomach

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

NCT01843829

Citation

J Clin Oncol 34, 2016 (suppl 4S; abstr 3)

DOI

10.1200/jco.2016.34.4_suppl.3

Abstract #

3

Abstract Disclosures