| Methods |
Design: 2‐arm parallel trial with a no‐treatment control group; stratification by type of pretreatment, location and grading of tumour, disease status (non‐responsive or recurrent)
No of centres: 1
Recruitment and setting: Medical Clinic and Department of Radiotherapy, University of Turin, Italy
Recruitment period: 01/84‐08/85
Observation period: median: 14 months, minimum: 11 months
Ethical approval: unclear |
| Participants |
No of patients: 48 randomised, 48 evaluated
Condition: squamous cell cancer of the oral cavity non‐responsive or recurrent after conventional therapy with surgery and/or irradiation
Demographics: men: 39, women: 9; mean age (range): 58 (37‐71) years
Informed consent: unclear |
| Interventions |
Interventional treatment: thymostimulin, dose/schedule: 1 mg/kg/day i.m. starting 7 days before chemotherapy treatment, thereafter 2x/week for 4 weeks and 1x/week until tumour progression
Control treatment: no treatment
Basic treatment: vincristine 1.2 mg/m² i.v. (d1), bleomycin 18 mg/m² i.m. (d1), methotrexate 30 mg/m² i.v. (d2); every week for 8 weeks |
| Outcomes |
Outcome measures: survival, response, toxicity (AEs of chemo‐/radiotherapy), other |
| Notes |
Outcomes: side effects of chemotherapy were not scored using standardized criteria |
