Prospective Review of Outlining in the UK NeoSCOPE Esophageal Trial

Gwynne, S.; Spezi, Emiliano; Maggs, R.; Jones, Gareth Wyn; Rackley, T.; Mukherjee, Somnath; Hawkins, M.; Radhakrishna, Ganesh; Ray, Ruby; Miles, Elizabeth; Crosby, Tom

doi:10.1016/j.ijrobp.2014.05.2135

Cited by 2 publications

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“…Cone-Beam CT verification was used on the first 3 fractions of radiotherapy treatment and weekly thereafter. The Radiotherapy Trials Quality Assurance (RTQA) process has been previously described and included a pre-accrual component, and on-trial real-time or timely retrospective review [17] , [18] .…”

Section: Methodsmentioning

confidence: 99%

NEOSCOPE: A randomised phase II study of induction chemotherapy followed by oxaliplatin/capecitabine or carboplatin/paclitaxel based pre-operative chemoradiation for resectable oesophageal adenocarcinoma

Mukherjee

Hurt

Gwynne³

et al. 2017

European Journal of Cancer

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BackgroundOxaliplatin-capecitabine (OxCap) and carboplatin-paclitaxel (CarPac) based neo-adjuvant chemoradiotherapy (nCRT) have shown promising activity in localised, resectable oesophageal cancer.Patients and methodsA non-blinded, randomised (1:1 via a centralised computer system), ‘pick a winner’ phase II trial. Patients with resectable oesophageal adenocarcinoma ≥ cT3 and/or ≥ cN1 were randomised to OxCapRT (oxaliplatin 85 mg/m2 day 1, 15, 29; capecitabine 625 mg/m2 bd on days of radiotherapy) or CarPacRT (carboplatin AUC2; paclitaxel 50 mg/m2 day 1, 8, 15, 22, 29). Radiotherapy dose was 45 Gy/25 fractions/5 weeks. Both arms received induction OxCap chemotherapy (2 × 3 week cycles of oxaliplatin 130 mg/m2 day 1, capecitabine 625 mg/m2 bd days 1–21). Surgery was performed 6–8 weeks after nCRT. Primary end-point was pathological complete response (pCR). Secondary end-points included toxicity, surgical morbidity/mortality, resection rate and overall survival.StatisticsBased on pCR ≤ 15% not warranting future investigation, but pCR ≥ 35% would, 76 patients (38/arm) gave 90% power (one-sided alpha 10%), implying that arm(s) having ≥10 pCR out of first 38 patients could be considered for phase III trials. ClinicalTrials.gov: NCT01843829. Funder: Cancer Research UK (C44694/A14614).ResultsEighty five patients were randomised between October 2013 and February 2015 from 17 UK centres. Three of 85 (3.5%) died during induction chemotherapy. Seventy-seven patients (OxCapRT = 36; CarPacRT = 41) underwent surgery. The 30-d post-operative mortality was 2/77 (2.6%). Grade III/IV toxicity was comparable between arms, although neutropenia was higher in the CarPacRT arm (21.4% versus 2.6%, p = 0.01). Twelve of 41 (29.3%) (10 of first 38 patients) and 4/36 (11.1%) achieved pCR in the CarPacRT and OxcapRT arms, respectively. Corresponding R0 resection rates were 33/41 (80.5%) and 26/36 (72.2%), respectively.ConclusionBoth regimens were well tolerated. Only CarPacRT passed the predefined pCR criteria for further investigation.

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Section: Methodsmentioning

confidence: 99%

NEOSCOPE: A randomised phase II study of induction chemotherapy followed by oxaliplatin/capecitabine or carboplatin/paclitaxel based pre-operative chemoradiation for resectable oesophageal adenocarcinoma

Mukherjee

Hurt

Gwynne³

et al. 2017

European Journal of Cancer

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“…The RT dose was 45 Gy in 25 daily fractions, delivered Monday to Friday as a 3D, conformally planned single-phase treatment and prescribed according to recommendations of the International Commission on Radiation Units and Measurements (ICRU-50). The trial included rigorous RT quality assurance as previously described [ 4 , 5 ]. Restaging CT/PET-CT was undertaken 4–6 weeks after CRT, and surgery was performed at 6–8 weeks after completion of CRT.…”

Section: Methodsmentioning

confidence: 99%

Oxaliplatin/capecitabine or carboplatin/paclitaxel-based preoperative chemoradiation for resectable oesophageal adenocarcinoma (NeoSCOPE): Long-term results of a randomised controlled trial

Mukherjee

Hurt

Radhakrishna

et al. 2021

European Journal of Cancer

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This is the first randomised study to evaluate toxicity and survival outcomes of two neoadjuvant chemoradiotherapy (CRT) regimens for patients with localised oesophageal adenocarcinoma (OAC) or gastro-oesophageal junction (GOJ) adenocarcinoma. The initial results showed comparable toxicity between regimens and pathological complete response (pCR) rate favouring CarPacRT. Herein, we report survival, progression patterns, and long-term toxicity after a median follow-up of 40.7 months. Methods: NeoSCOPE was an open-label, UK multicentre, randomised, phase II trial. Eightyfive patients with resectable OAC or GOJ adenocarcinoma, cT3 and/or cN1 (TNM v7), suitable for neoadjuvant CRT, were recruited between October 2013 and February 2015.Patients were randomised to OxCapRT (oxaliplatin 85 mg/m 2 on Days 1, 15, and 29; capecitabine 625 mg/m 2 orally twice daily on days of radiotherapy [RT]) or CarPacRT (carboplatin AUC2; paclitaxel 50 mg/m 2 on Days 1, 8, 15, 22, and 29). RT dose was 45 Gy/25 fractions/5 weeks. Both arms received induction chemotherapy (two cycles oxaliplatin 130 mg/m 2 on Day 1, capecitabine 625 mg/m 2 orally twice daily on Days 1e21) before CRT. Surgery was performed 6e8 weeks after CRT.The primary end-point was pCR. Secondary end-points were toxicity, progression-free survival (PFS), overall survival (OS), and patterns of progression. Results: Eighty-five patients were recruited from 17 UK centres. The median OS was 41.7 months (95% confidence interval [CI] 19.6 to not reached) in the OxCapRT arm and was not reached in the CarPacRT arm (multivariable hazard ratio [HR] Z 0.48, 95% CIs: 0.24 e0.95, P Z 0.035). The median PFS was 32.6 months (95% CIs: 17.1 to not reached) in the OxCapRT arm and was not reached in the CarPacRT arm (multivariable HR Z 0.54, 95% CIs: 0.29e1.01, P Z 0.053). In both arms, the distant progression was twice as common as locoregional progression. Conclusions: OS and PFS favoured neoadjuvant CarPacRT over OxCapRT. Distant was more common than locoregional progression; therefore, priority should be given to optimising the systemic treatment component.

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Prospective Review of Outlining in the UK NeoSCOPE Esophageal Trial

Cited by 2 publications

References 0 publications

NEOSCOPE: A randomised phase II study of induction chemotherapy followed by oxaliplatin/capecitabine or carboplatin/paclitaxel based pre-operative chemoradiation for resectable oesophageal adenocarcinoma

NEOSCOPE: A randomised phase II study of induction chemotherapy followed by oxaliplatin/capecitabine or carboplatin/paclitaxel based pre-operative chemoradiation for resectable oesophageal adenocarcinoma

Oxaliplatin/capecitabine or carboplatin/paclitaxel-based preoperative chemoradiation for resectable oesophageal adenocarcinoma (NeoSCOPE): Long-term results of a randomised controlled trial

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