APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
266<br />
Appendix 18<br />
Study details Population details Treatment details Results Interpretation<br />
Authors’ conclusions No conclusions<br />
specific to PDT<br />
Brief study appraisal This small<br />
study was an interim analysis of a RCT<br />
presented in abstract form. Although<br />
it indicated that updated results would<br />
be presented, no further information<br />
could be located. Most of the study’s<br />
methodological details were not<br />
available from the abstract and the<br />
majority of the results were not broken<br />
down by treatment group<br />
Mortality Assessed but not reported<br />
per group<br />
Morbidity Not assessed<br />
AEs Minor haemoptysis in two PDT-<br />
ERT patients. Skin photosensitivity was<br />
acceptable in patients treated with PDT<br />
(no data provided). Other AEs reported<br />
but not broken down by group<br />
Trial treatments ERT alone vs PDT<br />
preceding ERT vs HDR preceding ERT<br />
Intervention Photofrin 2 mg/kg,<br />
200 J/cm, 630 nm given 2 wk before ERT.<br />
Other PDT parameters not stated<br />
Comparator ERT alone:<br />
14 x 2.5 + 8 x 2.5 Gy to the tumour area<br />
in 4 wk<br />
2nd comparator HDR + ERT: As<br />
above preceded by HDR: 15 Gy at 1-cm<br />
distance along the tumour 2 wk before<br />
ERT<br />
Treatment intention<br />
Palliative<br />
Type of Lung Cancer<br />
and Histology Non-small<br />
cell; no further details<br />
given<br />
Main eligibility criteria<br />
Histologically proven<br />
inoperable locoregional<br />
NSCLC, weight loss < 10%<br />
and a PS (sic) > 70%<br />
Patient characteristics<br />
% Male: 88<br />
Concomitant<br />
treatment Not stated<br />
Authors Baas et al.<br />
(1994) 121<br />
Data source Abstract<br />
Country The<br />
Netherlands<br />
Language English<br />
Study design RCT<br />
No. of participants<br />
Total: 39<br />
Intervention: 15<br />
Comparator: 12<br />
2nd Comparator: 12<br />
No. of Recruiting<br />
Centres Not stated<br />
Follow-up period and<br />
frequency Not stated