Driving developments in UK oesophageal radiotherapy through the SCOPE trials

Gwynne, S.; Higgins, Elizabeth; King, A. Poon; Radhakrishna, Ganesh; Wills, L.; Mukherjee, Somnath; Hawkins, M.; Jones, Gareth Wyn; Staffurth, John; Crosby, T.

doi:10.1186/s13014-019-1225-0

Cited by 12 publications

(3 citation statements)

References 29 publications

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“…At the same time, the evaluation of tumor response by a variety of imaging methods can not only predict the prognosis, but also detect the non-responders and adjust neoadjuvant treatment strategy. In dCRT, the ongoing British SCOPE2 study [ 37 ] compare the effects of standard drugs and alternative combinations used in chemotherapy for patients who do not respond to standard drug chemotherapy in the early stage of treatment, as well as compares the effects of standard dose and high-dose radiotherapy. Our current study is dedicated to SCC histology only and compares radiation dose without switching chemotherapy regime.…”

Section: Discussionmentioning

confidence: 99%

Dose escalation based on 18F-FDG PET/CT response in definitive chemoradiotherapy of locally advanced esophageal squamous cell carcinoma: a phase III, open-label, randomized, controlled trial (ESO-Shanghai 12)

Zhu

Liu

et al. 2022

Radiat Oncol

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Introduction Definitive chemoradiotherapy has established the standard non-surgical treatment for locally advanced esophageal cancer. The standard dose of 50–50.4 Gy has been established decades ago and been confirmed in modern trials. The theorical advantage of better local control and technical advances for less toxicity have encouraged clinicians for dose escalation investigation. 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) have the potential to tailor therapy for esophageal patients not showing response to CRT and pioneers the PET-based dose escalation. Methods and analysis The ESO-Shanghai 12 trial is a prospective multicenter randomized phase 3 study in which patients are randomized to either 61.2 Gy or 50.4 Gy of radiation dose by PET response. Both groups undergo concurrent chemoradiotherapy with paclitaxel/cisplatin regimen for 2 cycles followed by consolidation chemotherapy for 2 cycles. Patients with histologically confirmed ESCC [T1N1-3M0, T2-4NxM0, TxNxM1 (Supraclavicular lymph node metastasis only), (AJCC Cancer Staging Manual, 8th Edition)] and without any prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer will be eligible. The primary endpoints included overall survival in PET/CT non-responders (SUVmax > 4.0) and overall survival in total population. Patients will be stratified by standardized uptake volume, gross tumor volume and tumor location. The enrollment could be ended, when the number of PET/CT non-responder reached 132 and the total population reached 646 for randomization. Ethics and dissemination This trial has been approved by the Fudan University Shanghai Cancer Center Institutional Review Board. Trial results will be disseminated via peer reviewed scientific journals and conference presentations. Trial registration The trial was initiated in 2018 and is currently recruiting patients. Trial registration number NCT03790553.

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Section: Discussionmentioning

confidence: 99%

Dose escalation based on 18F-FDG PET/CT response in definitive chemoradiotherapy of locally advanced esophageal squamous cell carcinoma: a phase III, open-label, randomized, controlled trial (ESO-Shanghai 12)

Zhu

Liu

et al. 2022

Radiat Oncol

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“…While the patients in the present study were treated with 3D-conformal radiotherapy, IMRT and VMAT represent current standards of care. Intensity-modulated radiotherapy techniques have fostered the use of integrated-boost irradiation and are under active investigation in prospective dose-escalation trials [ 33 ]. The simultaneous integrated boost (SIB) technique has been developed with the aim to increase the dose to macroscopic tumor (GTV) while simultaneously limiting the dose to normal tissues, particularly heart and lungs.…”

Section: Discussionmentioning

confidence: 99%

Dose-escalated radiotherapy with PET/CT based treatment planning in combination with induction and concurrent chemotherapy in locally advanced (uT3/T4) squamous cell cancer of the esophagus: mature results of a phase I/II trial

Pöttgen,

Gkika,

Stahl

et al. 2021

Radiat Oncol

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Background This prospective phase I/II trial assessed feasibility and efficacy of dose-escalated definitive chemoradiation after induction chemotherapy in locally advanced esophageal cancer. Primary study endpoint was loco-regional progression-free survival at 1 year. Methods Eligible patients received 2 cycles of induction chemotherapy with irinotecan, folinic acid and 5-fluorouracil weekly and cisplatin every 2 weeks (weeks 1–6, 8–13) followed by concurrent chemoradiation with cisplatin and irinotecan (weeks 14, 15, 17, 18, 20). Radiotherapy dose escalation was performed in three steps (60 Gy, 66 Gy, 72 Gy) using conventional fractionation, planning target volumes were delineated with the aid of 18F-FDG-PET/CT scans. During follow-up, endoscopic examinations were performed at regular intervals. Results Between 09/2006 and 02/2010, 17 patients were enrolled (male/female:13/4, median age: 59 [range 48–66] years, stage uT3N0/T3N1/T4N1: 4/12/1). One patient progressed during induction chemotherapy and underwent surgery. Of 16 patients treated with definitive chemoradiotherapy, 9 (56%) achieved complete response after completion of chemoradiation. One-, 2-, 3- and 5-year overall survival rates (OS) were 77% [95%CI: 59–100], 53% [34–83], 41% [23–73], and 29% [14–61], respectively. Loco-regional progression-free survival at 1, 3, and 5 years was 59% [40–88], 35% [19–67], and 29% [14–61], corresponding cumulative incidences of loco-regional progressions were 18% [4–39%], 35% [14–58%], and 41% [17–64%]. No treatment related deaths occurred. Grade 3 toxicities during induction therapy were: neutropenia (41%), diarrhoea (41%), during combined treatment: neutropenia (62%) and thrombocytopenia (25%). Conclusions Dose-escalated radiotherapy and concurrent cisplatin/irinotecan after cisplatin/irinotecan/5FU induction chemotherapy was tolerable. The hypothesized phase II one-year loco-regional progression free survival rate of 74% was not achieved. Long-term survival compares well with other studies on definitive radiotherapy using irinotecan and cisplatin but is not better than recent trials using conventionally fractionated radiotherapy ad 50 Gy with concurrent paclitaxel or 5FU and platinum compound. Trial registration The present trial was registered as a phase I/II trial at the EudraCT database: Nr. 2005-006097-10 (https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-006097-10/DE) and authorized to proceed on 2006-09-25.

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“…An important additional component of the study is the investigation of adaptive therapy, in that it incorporates a phase II trial for patients with a poor early response using positron emission tomography/computed tomography. SCOPE 2 builds on the success of the SCOPE trial [12], which, although negative in terms of the primary outcome measures (testing the addition of cetuximab to chemoradiotherapy for oesophageal cancer), defined the standard of care regimen (two cycles of cisplatin and 5fluorouracil) and radiotherapy volume definition and planning technique (50 Gy in 20 fractions, conformally planned) across the UK [13]. In terms of defining standard practice, SCOPE was accompanied by NeoSCOPE, assisting the re-introduction of neoadjuvant chemoradiotherapy in operable oesophageal cancer e again the associated radiotherapy quality assurance programme [14,15] was credited with adoption across UK centres and formed the basis of treatment protocols worldwide.…”

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confidence: 99%