High energy neutron treatment for pelvic cancers: study stopped because of increased mortality.
OBJECTIVE
To compare high energy fast neutron treatment with conventional megavoltage x ray treatment in the management of locally advanced pelvic carcinomas (of the cervix, bladder, prostate, and rectum).


METHODS
Randomised study from February 1986; randomisation to neutron treatment or photon treatment was unstratified and in the ratio of 3 to 1 until January 1988, when randomisation was in the ratio 1 to 1 and stratified by site of tumour.


METHODS
Mersey regional radiotherapy centre at Clatterbridge Hospital, Wirral.


METHODS
151 patients with locally advanced, non-metastatic pelvic cancer (27 cervical, 69 of the bladder, seven prostatic, and 48 of the rectum).


METHODS
Randomisation to neutron treatment was stopped in February 1990.


METHODS
Patient survival and causes of death in relation to the development of metastatic disease and treatment related morbidity.


RESULTS
In the first phase of the trial 42 patients were randomised to neutron treatment and 14 to photon treatment, and in the second phase 48 to neutron treatment and 47 to photon treatment. The relative risk of mortality for photons compared with neutrons was 0.66 (95% confidence interval 0.40 to 1.10) after adjustment for site of tumour and other important prognostic factors. Short term and long term complications were similar in both groups.


CONCLUSIONS
The trial was stopped because of the increased mortality in patients with cancer of the cervix, bladder, or rectum treated with neutrons.
Errington
R D
RD
Medical Research Council Cyclotron Unit, Mersey Regional Centre for Radiotherapy and Oncology, Clatterbridge Hospital, Wirral.
Ashby
D
D
Gore
S M
SM
Abrams
K R
KR
Myint
S
S
Bonnett
D E
DE
Blake
S W
SW
Saxton
T E
TE
D005214:Fast Neutrons / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009362:Neoplasm Metastasis; D010386:Pelvic Neoplasms / Q000401:mortality / Q000532:radiotherapy*; D011379:Prognosis; D011471:Prostatic Neoplasms / Q000532:radiotherapy; D011882:Radiotherapy, High-Energy; D012004:Rectal Neoplasms / Q000401:mortality / Q000532:radiotherapy; D012107:Research Design; D012306:Risk; D013997:Time Factors; D001749:Urinary Bladder Neoplasms / Q000401:mortality / Q000532:radiotherapy; D002583:Uterine Cervical Neoplasms / Q000401:mortality / Q000532:radiotherapy