A randomised phase II/III multi-centre clinical trial of definitive chemo-radiaiton, with or without cetuximab, in carcinoma of the oesophagus - SCOPE 1

Phase 1

• Conditions: in-operable carcinoma of the oesophagus; MedDRA version: 8.1 Level: LLT Classification code 10030151 Term: Oesophageal cancer

• Registration Number: EUCTR2006-002241-37-GB
• Lead Sponsor: Velindre NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-26
• Study Completion: 2012-10-10
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Older than 18 years of age.
2.Have been selected to receive potentially curative definitive chemo-radiation by a specialist Upper GI MDT including a designated upper GI surgeon.
3.Who are not suitable for surgery either for medical reasons or through patient choice.
4.Histologically confirmed carcinoma of the oesophagus (adenocarcinoma, squamous cell or undifferentiated carcinoma) 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.
5.Tumours staged with both endoscopic ultrasound (EUS) and spiral CT scan to be T1-4, N0-1 confirming localised, non-metastatic disease (both within 6 weeks prior to randomisation, but the most recent within 4 weeks).
6.Total disease length (primary and lymph nodes) less than 10cm defined by EUS.
7.Patients clear of previous malignancies for a period of 5 years prior to randomisation.
8.WHO performance status 0-1.
9.Adequate cardiovascular function for safe delivery of chemo-radiation in the opinion of the principal investigator.
•Where there is clinical concern patients should have an adequate cardiac ejection fraction = 40% as determined by MUGA scan or ECHO (within 4 weeks prior to randomisation).
10.Adequate respiratory function for safe delivery of chemo-radiation in the opinion of the principal investigator.
•Where there is clinical concern FEV1 = 1 litre as determined by spirometry (within 4 weeks prior to randomisation).
11.Adequate bone marrow and hepatic function (within 1 week prior to randomisation)
•Absolute neutrophil count (ANC) = 1.5x109/L
•White blood cell count = 3x109/L
•Platelets = 100x109/L
•Haemoglobin (Hb) = 10g/dL (patients Hb should be corrected to >10g/dl before treatment)
•Adequate liver function (within 1 week prior to randomisation)
•Serum bilirubin = 1.5x ULN
•ALT / AST = 2.5x ULN
•ALP = 3x ULN
12.Adequate renal function (within 1 week prior to randomisation)
•Glomerular filtration rate (GFR) assessed by EDTA clearance to be > 40mL/min (or estimated by Cockcroft-Gault formula to be > 60 mL/min).
13.Patients who are fit to receive all protocol treatment.
14.Patients who are able and willing to administer capecitabine.
15.Patients who are of child bearing age are willing to use contraception.
16.Patients who have completed baseline quality of life questionnaires.
17.Patients who have provided written informed consent prior to randomisation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients who have had previous treatment for invasive oesophageal carcinoma or gastro-oesophageal junction carcinoma (not including PDT or laser therapy for high grade dysplasia/carcinoma in-situ).
2.Patients with metastatic disease i.e. M1a or M1b according to UICC TNM version 6.
3.Patients with previous treatment for malignancy which compromises the ability to deliver definitive mediastinal chemo-radiation or may compromise survival.
4. patients who have had a previous malignancy during the previous 5 years
5.Patients with significant (>2cm) extension of tumour into the stomach.
6.Patients with unstable angina or uncontrolled hypertension or cardiac failure or other clinically significant cardiac disease.
7.Patients who have had major surgery or major trauma in the 4 weeks prior to randomisation.
8.Patients who have been treated with a monoclonal antibody in the 4 weeks prior to randomisation.
9.Patients who have been treated with radiotherapy in the 3 months prior to randomisation.
10.Patients who need continued treatment with a contraindicated concomitant medication or therapy.
11.Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
12.Patients with hearing impairment or sensory-motor neuropathy of WHO grade > 2.
13.Women who are pregnant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether the addition of cetuximab to definitive chemo-radiation (CRT) results in increased survivial, and is safe and feasible to use in the treatment of patients with non-metastatic carcinoma of the oesophagus.;<br> Secondary Objective: Toxicity<br> Feasibility<br> Health Economics<br> Quality of Life<br> Quality Assurance<br> ;<br> Primary end point(s): Overall Survival. Overall survival is calculated from the date of randomisation, to death from any cause.<br> Those still alive will be censored at the last time seen.<br>