A randomised controlled trial of intervention site radiotherapy in malignant pleural mesothelioma
N = 61
- Population
- 61 patients (56 men, 5 women, median age 70) with pleural mesothelioma and an invasive procedure in the preceding 21 days
- Design
- Randomised controlled trial in two centres, 1998 to 2004: 61 patients with a histological diagnosis of pleural mesothelioma and an invasive procedure within the preceding 21 days, stratified by age, performance status and treatment centre, randomised between immediate drain-site radiotherapy (21 Gy in three fractions) and best supportive care, with follow-up to 12 months; 31 were allocated to radiotherapy. Seven patients developed tract metastases associated with the drain site (four radiotherapy, three best supportive care) and four developed metastases associated with subsequent procedures at other sites (three radiotherapy, one best supportive care); two patients developed two tract metastases each. No statistically significant difference in the risk of tract metastasis associated with the drain site (p=0.748). The counting unit is the patient.
- Arms
- Best supportive care (control): Best supportive care without drain-site radiotherapy
- Drain-site radiotherapy (experimental, n = 31): Immediate drain-site radiotherapy, 21 Gy in three fractions
- People
- O'Rourke N, senior author Hill J