Cisplatin, capecitabine, and radiation therapy with or without cetuximab in treating patients with oesophageal cancer
| ISRCTN | ISRCTN47718479 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47718479 |
| ClinicalTrials.gov (NCT) | NCT00509561 |
| Clinical Trials Information System (CTIS) | 2006-002241-37 |
| Protocol serial number | WCTU01 |
| Sponsor | Velindre NHS Trust (UK) |
| Funder | Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) (ref: C20177/A6386) |
- Submission date
- 20/04/2006
- Registration date
- 18/05/2006
- Last edited
- 19/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Tom Crosby
Scientific
Scientific
Velindre Hospital
Whitchurch
Cardiff
CF14 2TL
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-arm open randomised phase II/III trial with a 1:1 randomisation ratio |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus |
| Study acronym | SCOPE 1 |
| Study objectives | Patients with histologically confirmed carcinoma of the oesophagus, squamous cell or adenocarcinoma, (considered suitable for definitive chemoradiation by an accredited multi-disciplinary team [MDT] including a specialist upper gastrointestinal [GI] surgeon), will be randomised to receive definitive chemoradiation treatment (CRT) with or without cetuximab. On 11/02/2009 the overall trial start and end dates were amended. The initial dates at the time of registration were: Initial overall trial start date: 01/06/2007 Initial overall trial end date: 01/06/2012 All other changes to this record can be found in the relevant field under the update date of 11/02/2009. |
| Ethics approval(s) | Research Ethics Committee for Wales gave multicentre approval on 17/04/2007 |
| Health condition(s) or problem(s) studied | Oesophageal cancer |
| Intervention | Control arm: chemoradiation Experimental arm: chemoradiation plus cetuximab |
| Intervention type | Drug |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Cisplatin, capecitabine, radiation therapy, cetuximab |
| Primary outcome measure(s) |
Phase II: treatment failure |
| Key secondary outcome measure(s) |
Phase II: |
| Completion date | 01/02/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 420 |
| Key inclusion criteria | Amended 11/02/2009: The following points of the below criteria have been amended as follows: 2. Histologically confirmed carcinoma of the oesophagus (adenocarcinoma, squamous cell, or undifferentiated) or Siewert type 1 tumour of the gastro-oesophageal junction (GOJ) or Siewert Type 2 with no more than 2 cm mucosal extension into the stomach 3. Tumours staged with endoscopic ultrasonography (EUS) and spiral computerised tomography (CT) scan to be T1-4N0-1 confirming localised, non-metastatic disease 7. Adequate cardio-respiratory function for definitive CRT. (Echo or multiple-gated acquisition left ventricular (MUGA LV) function greater than 40% (no acute coronary event in previous six months, myocardial infarction or unstable angina), forced expiratory volume in one second (FEV1) greater than 1 litre) 8. Adequate renal function for definitive CRT (renal glomerular filtration rate greater than 60 ml/min (calculated using Cockroft formula with ethylenediaminetetraacetic acid (EDTA) if predicted less than 60 ml/min 9. Written informed consent to participate in the trial Initial information at time of registration: 1. Patients older than 18 years of age who have been selected to receive potentially curative definitive chemo-radiation 2. Histologically confirmed carcinoma of the oesophagus (adenocarcinoma or squamous cell) or Siewert type 1 tumour of the gastro-oesophageal junction (GOJ) 3. Tumours staged with endorectal ultrasonography (EUS) and spiral computerised tomography (CT) scan to be T1-4N0-1 confirming localised, non-metastatic disease 4. Total disease length (primary tumour and lymph nodes) less than 10 cm defined by EUS 5. World Health Organization (WHO) performance status 0 or 1 6. Patients physically and psychologically fit and willing to receive definitive chemoradiation with or without cetuximab 7. Adequate cardio-respiratory function for definitive CRT. Echo or multiple-gated acquisition left ventricular (MUGA LV) function greater than 40% (no acute coronary event in previous six months, myocardial infarction or unstable angina), forced expiratory volume in one second (FEV1) greater than 1 litre, renal glomerular filtration rate greater than 60 ml/min (calculated using Cockroft formula with ethylenediaminetetraacetic acid (EDTA) if predicted less than 60 ml/min). 8. Written informed consent to participate in the trial |
| Key exclusion criteria | Amended 11/02/2009: The following points of the below criteria have been amended as follows: 3. Patients with previous treatment for malignancy, which will compromise ability to deliver definitive mediastinal chemoradiation or may compromise survival Initial information at time of registration: 1. Patients who have had previous treatment for oesophageal carcinoma 2. Patients with metastatic disease i.e. M1a/coeliac nodes or M1b 3. Patients with previous treatment for malignancy, which will compromise ability to deliver definitive mediastinal chemoradiation 4. Patients with significant (greater than 2 cm) extension of tumour into the stomach |
| Date of first enrolment | 07/02/2008 |
| Date of final enrolment | 06/02/2011 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Velindre Hospital
Cardiff
CF14 2TL
United Kingdom
CF14 2TL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2013 | Yes | No | |
| Results article | results | 14/03/2017 | Yes | No | |
| Protocol article | protocol | 28/10/2011 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes | |||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/03/2020: EudraCT number added. Added EudraCT link to basic results (scientific).
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
28/03/2018: Three publication references added.
