Trial and study on nephroblastomas S.I.O.P. No. 1.
The International Society of Paediatric Oncology (S.I.O.P.) organised a study and trial on nephroblastomas in September 1971. This first trial was stopped in October 1974. In this period, 398 patients were included in trial and study. Patients came from 42 Centres in 14 countries. Eligible for the clinical trial were 195 patients. The clinical trial consisted of 2 parts: Part 1. Radiotherapy: Pre- and post-operative radiotherapy versus post-operative radiotherapy alone. Part 2. Chemotherapy: One single course of actinomycin D versus multiple courses of actinomycin D. For the radiotherapy trial, 137 cases were suitable after randomization. Concerning the recurrence-free survival, there were no significant differences following the actuarial statistical method. The same for survival. There was a high rate of ruptures in the post-operative group. These ruptured cases caused a higher rate of metastases and asked for a heavier treatment. Especially because of these ruptured cases the conclusion is drawn that pre- and post-operative radiotherapy is a better way of treatment for nephroblastomas when they cannot be expected to be a stage I tumour on clinical grounds. For the chemotherapy trial, 160 cases were suitable. There was no difference between the group of patients receiving a single course versus multiple courses of actinomycin D. Disease-free interval and survival in both groups in all stages were the same. The conclusion is drawn that this way of treatmetn does not make any difference. In a second study, chemotherapy with two agents is considered in two groups of patients receiving 6 months chemotherapy vincristine and actinomycin D versus 15 months.
D002648:Child; D002986:Clinical Trials as Topic; D003609:Dactinomycin / Q000627:therapeutic use; D006801:Humans; D007391:International Cooperation; D008511:Medicine; D012955:Societies, Medical; D013038:Specialization; D009396:Wilms Tumor / Q000188:drug therapy / Q000532:radiotherapy
D003609:Dactinomycin