EUCTR2006-002241-37-GBActive, not recruitingPhase 1
A randomised phase II/III multi-centre clinical trial of definitive chemo-radiaiton, with or without cetuximab, in carcinoma of the oesophagus - SCOPE 1
Velindre NHS Trust0 sites0 target enrollmentStarted: February 26, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
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.
Investigators
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