A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer
NeoSCOPE
A Randomised Phase II Study of Two Pre-operative Chemoradiotherapy Regimens (Oxaliplatin and Capecitabine Followed by Radiotherapy With Either Oxaliplatin and Capecitabine or Paclitaxel and Carboplatin) for Resectable Oesophageal Cancer
1 other identifier
interventional
85
1 country
12
Brief Summary
About 7500 patients are diagnosed with oesophageal cancer each year in the UK of which less than a quarter have resectable disease at diagnosis. There is a general lack of consistency in the standard of care for patients across UK hospitals. Patients are either treated with a) chemotherapy followed by surgical removal of the tumour, or b) chemoradiotherapy followed by removal of the tumour by surgery, as part of their standard of care. Recent research supports the latter treatment, as chemoradiotherapy maybe more effective at shrinking the tumour and preventing the disease from spreading than taking chemotherapy alone. However, there is no definitive way of identifying which treatment is best without a clinical trial. Evidence suggests that the effect of the chemoradiotherapy currently used as standard practice may be improved and the side effects reduced by using a different chemoradiotherapy combination. In this trial, eligible patients will receive 2 cycles of the same chemotherapy before being randomised to receive two different chemoradiotherapy regimens (carboplatin and paclitaxel verses oxaliplatin and capecitabine) both of which have shown promising results in previous studies. Patients will then have their tumour removed. The best chemoradiotherapy regimen will then be taken forward to a Phase III trial in which chemoradiotherapy will be compared with chemotherapy alone. The efficacy of the regimens will be measured by counting the number of patients who i) remain free from cancer, ii)have local or distant spread of their cancer, iii) are successfully recruited and iv) experience toxicities. A specific set of toxicity criteria will be used to monitor any treatment induced side-effects and provide justification for any necessary dose modifications or withdrawal of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2013
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2013
CompletedFirst Posted
Study publicly available on registry
May 1, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMarch 24, 2014
March 1, 2014
1.6 years
March 7, 2013
March 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy
The efficacy of the trial treatment will be assessed by conducting analysis on the resected tumour specimen of participants undergoing surgery. This will be achieved by looking at the pathological complete response rate (pCR).
24 months
Secondary Outcomes (4)
Feasibility of recruiting 62 patients within 18 months
18 months
Safety
3 years
Efficacy
5 years
Efficacy
24 months
Study Arms (2)
Carboplatin and Paclitaxel Arm
EXPERIMENTAL2 cycles OxCap: Oxaliplatin 130mg/m2 Day 1 (IV infusion) Capecitabine 625mg/m2 bd Day 1- 21 (oral) then CRT: Paclitaxel 50mg/m2 Days 1,8,15,22,29 (IV infusion); Carboplatin AUC 2 Days 1,8,15,22,29 (IV infusion) XRT: 45 Gy in 25 fractions then surgery. All drugs will be sourced from local stock
Oxaliplatin and Capecitabine Arm
EXPERIMENTAL2 cycles OxCap: Oxaliplatin 130mg/m2 Day 1 (IV infusion) Capecitabine 625mg/m2 bd Day 1- 21 (oral) then CRT: Oxaliplatin 85mg/m2 Days 1, 15, 29 (IV infusion); Capecitabine 625mg/m2 bd (oral) only on days when receiving RT XRT: 45 Gy in 25 fractions\* then surgery. All drugs will be sourced from local stock
Interventions
Patients will have their tumour surgically removed by two-phase oesophagectomy and two-field lymphadenectomy.
Eligibility Criteria
You may qualify if:
- Histologically confirmed operable oesophageal cancer (adenocarcinoma)
- Tumour must be staged as a T3, 4 or N1 (using TNM6 staging) or T3, T4a or N13 using TNM7 staging)
- Maximum disease (Tumour plus nodes) length 8 cm staged with EUS and CT/PET
- WHO performance status 01
- Adequate haematological, renal, respiratory, cardiac and hepatic function
- The patient has provided written informed consent.
You may not qualify if:
- Histologically confirmed operable oesophageal cancer (squamous cell carcinoma)
- Uncontrolled angina pectoris, myocardial infarction within 6 months, heart failure, clinically significant uncontrolled cardiac arrhythmias, or any patient with a clinically significant abnormal ECG.
- Patients with any previous treatment for oesophageal carcinoma.
- Siewert type 3 oesophagogastric tumours.
- T4 tumours invading contiguous structures other than diaphragm, crura or mediastinal pleura.
- Patients with disease in any of the following areas on the CT scan, EUS or other staging investigation:
- Evidence of metastases in liver, lung, bone or other distant metastases.
- Abdominal para aortic lymphadenopathy \>1cm diameter on CT or \>6mm diameter on EUS.
- Invasion of tracheo-bronchial tree, aorta, pericardium or lung.
- Lymphadenopathy encasing the coeliac axis (as described above, patients with single nodes lying anterior to the origin of the splenic artery and anterior to the origin of the coeliac axis are not excluded).
- Any patient with a single significant medical condition which is thought likely to compromise his or her ability to tolerate any of the above therapies.
- Specific contraindications to surgery, chemotherapeutic agents (including known allergies to chemotherapy) or radiotherapy.
- Pregnant or lactating women and fertile women who will not be using adequate contraception during the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lisette Nixonlead
- Cancer Research UKcollaborator
Study Sites (12)
Bristol Oncology and Haematology Centre
Bristol, United Kingdom
Valindre NHS
Cardiff, United Kingdom
University Hospitals Coventry and Warwickshire
Coventry, United Kingdom
Royal Derby Hospital
Derby, United Kingdom
St James's Hospital
Leeds, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
St Mary's Hopsital
London, United Kingdom
The Christie
Manchester, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Weston Park Hospital
Sheffield, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
The Great Western Hospital
Swindon, United Kingdom
Related Publications (3)
Mukherjee S, Hurt C, Radhakrishna G, Gwynne S, Bateman A, Gollins S, Hawkins MA, Canham J, Grabsch HI, Falk S, Sharma RA, Ray R, Roy R, Cox C, Maynard N, Nixon L, Sebag-Montefiore DJ, Maughan T, Griffiths GO, Crosby TDL. Oxaliplatin/capecitabine or carboplatin/paclitaxel-based preoperative chemoradiation for resectable oesophageal adenocarcinoma (NeoSCOPE): Long-term results of a randomised controlled trial. Eur J Cancer. 2021 Aug;153:153-161. doi: 10.1016/j.ejca.2021.05.020. Epub 2021 Jun 20.
PMID: 34157617DERIVEDMukherjee S, Hurt CN, Gwynne S, Sebag-Montefiore D, Radhakrishna G, Gollins S, Hawkins M, Grabsch HI, Jones G, Falk S, Sharma R, Bateman A, Roy R, Ray R, Canham J, Griffiths G, Maughan T, Crosby T. NEOSCOPE: A randomised phase II study of induction chemotherapy followed by oxaliplatin/capecitabine or carboplatin/paclitaxel based pre-operative chemoradiation for resectable oesophageal adenocarcinoma. Eur J Cancer. 2017 Mar;74:38-46. doi: 10.1016/j.ejca.2016.11.031. Epub 2017 Feb 8.
PMID: 28335886DERIVEDMukherjee S, Hurt CN, Gwynne S, Bateman A, Gollins S, Radhakrishna G, Hawkins M, Canham J, Lewis W, Grabsch HI, Sharma RA, Wade W, Maggs R, Tranter B, Roberts A, Sebag-Montefiore D, Maughan T, Griffiths G, Crosby T. NEOSCOPE: a randomised Phase II study of induction chemotherapy followed by either oxaliplatin/capecitabine or paclitaxel/carboplatin based chemoradiation as pre-operative regimen for resectable oesophageal adenocarcinoma. BMC Cancer. 2015 Feb 12;15:48. doi: 10.1186/s12885-015-1062-y.
PMID: 25880814DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior Trial Manager
Study Record Dates
First Submitted
March 7, 2013
First Posted
May 1, 2013
Study Start
October 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2016
Last Updated
March 24, 2014
Record last verified: 2014-03