APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
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DOI: 10.3310/hta14370 <strong>Health</strong> <strong>Technology</strong> <strong>Assessment</strong> 2010; Vol. 14: No. 37<br />
Study details Population details Treatment details Results Interpretation<br />
Authors’ conclusions The data<br />
from this trial support the use of<br />
the optimal regimen of ALA in a<br />
RCT of ALA vs Photofrin PDT<br />
Brief study appraisal This small<br />
study is reported in abstract form<br />
only and no further publication is<br />
available. It is, therefore, difficult to<br />
assess the quality of the trial and<br />
the reliability of the findings<br />
Mortality Not assessed<br />
Morbidity Patients in the group receiving<br />
High-dose ALA–PDT and High-dose red<br />
light had a significant decrease in cancer risk<br />
when compared with the other treatment<br />
groups at 36 mth (24% risk vs 3%). The<br />
difference in adenocarcinoma rates were<br />
significant when red light was compared<br />
with green (8% vs 45%, p < 0.05)<br />
AEs No patients suffered photosensitivity<br />
reactions or developed oesophageal<br />
strictures<br />
Resource use Not assessed<br />
Trial treatments High-dose ALA<br />
(60 mg/kg) with High-dose red or<br />
green light (1000 J/cm) vs High-dose<br />
ALA (60 mg/kg) with low-dose red<br />
light (500–700 J/cm) vs Low-dose<br />
ALA (30 mg/kg) with high-dose red<br />
or green light (1000 J/cm)<br />
Intervention High-dose ALA<br />
(60 mg/kg) with high-dose red or<br />
green light (1000 J/cm)<br />
Comparator High-dose ALA<br />
(60 mg/kg) with low-dose red light<br />
(500–700 J/cm)<br />
2nd comparator Low-dose ALA<br />
(30 mg/kg) with high-dose red or<br />
green light (1000 J/cm)<br />
Treatment intention<br />
Not stated<br />
Type(s) of cancer<br />
and histology BO with<br />
HGD<br />
Main eligibility<br />
criteria Not stated<br />
Patient<br />
characteristics Not<br />
stated<br />
Concomitant<br />
treatment Not stated<br />
Authors Mackenzie et al.<br />
(2007) 103<br />
Linked publications205 Data source Abstract<br />
Country UK<br />
Language English<br />
Study design RCT<br />
No. of participants<br />
Total: 24 appeared to have<br />
been randomised to either<br />
red or green light and were<br />
part of a larger study of 72<br />
patients<br />
Intervention: High-dose ALA<br />
(60 mg/kg) with high-dose red<br />
or green light (1000 J/cm) –<br />
not stated<br />
Comparator: High-dose ALA<br />
(60 mg/kg) with low-dose red<br />
light (500–700 J/cm) – not<br />
stated<br />
2nd Comparator: Low-dose<br />
ALA (30 mg/kg) with highdose<br />
red or green light<br />
(1000 J/cm) – not stated<br />
No. of recruiting centres<br />
Not stated<br />
Follow-up period and<br />
frequency 36 mth<br />
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