Kaye 1989.

Study characteristics
Methods	This was a randomised, open‐label, parallel‐group trial.
Participants	The study recruited 103 participants (52 in the combined‐therapy group and 51 in the conservative‐therapy group) with histologically‐proven MF of all stages. Demographics of the included participants 69 men and 34 women Age < 60 years: 65 participants; ≥ 60 years: 38 participants Stages of disease: IA: 6, IB: 16, IIA: 9, IIB: 12; III: 2, IVA: 42, IVB: 16 8 participants were lost to follow‐up (6/52 = 11.5% in the combined‐therapy group; 2/51 = 3.9% in the conservative‐treatment group), resulting in 103 participants evaluated (last observation carried forward; participants were suspected to be still alive) Exclusion criteria of the trial Eastern Cooperative Oncology Group Performance Status > 3 (bedridden participant) related to other causes than MF Prior systemic chemotherapy Prior total‐skin electron‐beam therapy
Interventions	The combined‐therapy group was given electron‐beam radiation (3000 cGy to 3200 cGy additional boost of 1000 cGy to 1500 cGy to the top of the head, perineum, and soles of the feet) and parenteral chemotherapy (cyclophosphamide 500 mg/m² (day 1), doxorubicin 50 mg/m² (day 1), etoposide 100 mg/m² (day 1 to 3), vincristine 1.4 mg/m², with a maximum dose of 2 mg (day 1). The conservative group was given topical treatment with 10 mg mechlorethamine applied to the entire skin alone or in combination with sequential escape therapies in case of visceral involvement or progressive disease: a) oral methotrexate (20 mg/m² orally twice weekly for stage IVB participants) b) PUVA (oral methoxsalen 0.6 mg/kg body weight followed by UVA light therapy 3 x/week) c) electron‐beam therapy (as described in the combined‐therapy group) combined with methotrexate (as described above) d) systemic chemotherapy (as described in the combined‐therapy group)
Outcomes	Outcomes of the trial Common adverse effects of the treatments Percentage of participants demonstrating complete response Relapse defined as the time period after remission when the eruption reappears after short‐term clearance Disease‐free survival Overall survival (assessed more than 5 years after the end of the intervention) Objective response rate
Notes	The funding body was not declared. No conflicts of interests reported. This study was conducted in 7 secondary/tertiary care centres in the USA.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Stratified block randomisation was undertaken.
Allocation concealment (selection bias)	Unclear risk	The study did not provide information about this. We sought information but got no response.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	This was not possible because of different interventions used.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	The study did not provide information about this. We sought information but got no response.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	ITT analysis and last observation carried forward was carried out. There were 6/52 (12%) dropouts in the combined‐therapy group (2 refused to receive treatment; 1 withdrew because of congestive heart failure; 1 withdrew because of residual cutaneous disease; and 2 refused treatment after clinical response) and 2/51 (4%) in conservative‐treatment group (no reasons were stated).
Selective reporting (reporting bias)	Unclear risk	This was unknown. We contacted the corresponding author for additional outcome data, and the author requested original data from their former employer, but the data were not available so far.
Other bias	Unclear risk	It was unclear if previous treatment was stopped.