EUCTR2005-005528-15-GBActive, not recruitingPhase 1
A RANDOMISED CONTROLLED TRIAL TO STUDY THE SIDE EFFECT PROFILE AND TO ESTABLISH MEASURES OF EFFICACY USING PHOTOFRIN OR 5 AMINOLAEVULINIC ACID PHOTODYNAMIC THERAPY IN THE ERADICATION OF DYSPLASIA IN BARRETT’S COLUMNAR LINED OESOPHAGUS - RCT of ALA and Photofrin PDT for HGD in Barrett's Oesophagus
niversity College London0 sites64 target enrollmentStarted: December 19, 2005Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 64
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •1.Patients will be recruited from those referred to the National Medical Laser Centre for management of HGD in BE.
- •2.Patients with biopsy proven Barrett’s Columnar Lined Oesophagus and high-grade dysplasia confirmed by 2 independent pathologists, and no evidence of invasive cancer. Biopsies will be taken at surveillance endoscopy from each quadrant of the oesophagus every 2 cm through the length of the Barrett’s Oesophagus segment.
- •3.Patients with a visible distinct nodule of HGD will be eligible for inclusion following endoscopic mucosal resection or other ablative therapy to this nodule provided residual HGD remains in the patient’s Barrett’s segment.
- •4.Patients may have an endoscopic ultrasound to confirm non-invasive disease as clinically indicated.
- •5.Patients to be double stratified into:
- •(a) Short or Long Segment BE: Short segment defined as 6 cm or less (single length treatment) and Long segment defined as >6cm but up to 13cm (double length treatment)
- •(b) Single or Multiple sites of high grade dysplasia.
- •5The maximum length of Barrett’s oesophagus eligible for inclusion into the study will be 13cm.
- •6Patients must have no contraindications to endoscopy.
- •7Males and non-pregnant females over the age of 21 years. Female patients who are pre-menopausal must practice a medically acceptable form of contraception.
- •8Patients must sign an informed consent form.
- •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
- •1Presence of invasive carcinoma of the oesophagus.
- •2History of severe cardiovascular disease, severe angina, congestive heart failure, or recent syncope of cardiovascular origin.
- •3Patients presenting with abnormal cardiac signs or symptoms and signs of congestive heart failure on physical examination.
- •4Patients with orthostatic hypotension resistant to hydration.
- •5Patients in whom endoscopy is contraindicated.
- •6Patients who have a history of porphyria, or hypersensitivity to porphyrins.
- •7Patients taking depot preparations of psychotropic medication
- •8Patients with a WBC <2x109/L.
- •9Patients with a platelet count <50x109/L.
- •10Patients with a prothrombin time >1.5 times the upper limit of normal.
- •11Patients with impaired renal and/or hepatic function at time of entry into the study (total serum bilirubin >50 mcmol/L, serum creatinine >200 mcmol/L, alkaline phosphatase (of hepatic origin) and/or ALT >2 times upper limit of normal).
- •12Patients are not allowed to receive concurrent chemotherapy, or radiation therapy or chemotherapy within 4 weeks of entry into this study.
- •13Patients with prior PDT for Barrett’s Columnar Lined Oesophagus.
- •14Barrett’s Oesophagus greater than 13cm in length.
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