Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
-
Randomized Controlled Trial Multicenter Study Comparative Study
20 Gy versus 44 Gy supplemental beam radiation with Pd-103 prostate brachytherapy: preliminary biochemical outcomes from a prospective randomized multi-center trial.
While favorable results are achieved with combined modality irradiation, there has never been a rigorous study of the need for supplemental beam. The study reported here compares clinical outcomes with substantially different external beam radiation doses. Similar to classic randomized Wilm's tumor studies from the 1980s, the intention of the trial design was to decrementally test the need for beam radiation. ⋯ The randomized data presented here suggests that the likelihood of biochemical cure is similar with standard (44 Gy) or lower dose (20 Gy) supplemental beam radiation. Since the biological effect of 20 Gy external beam radiation is likely to be small, we interpret these preliminary results to suggest that supplemental beam radiation is unnecessary, in the setting of a high degree of prostate coverage by the brachytherapy prescription dose. With closure of this study, we have begun treating intermediate and high risk patients on a prospective randomized comparison of Pd-103 with 20 versus 0 Gy supplemental beam radiation.
-
Randomized Controlled Trial Comparative Study Clinical Trial
Randomized trial of 8 Gy in 1 versus 20 Gy in 5 fractions of radiotherapy for neuropathic pain due to bone metastases (Trans-Tasman Radiation Oncology Group, TROG 96.05).
Despite numerous randomized trials investigating radiotherapy (RT) fractionation schedules for painful bone metastases, there are very few data on RT for bone metastases causing pain with a neuropathic component. The Trans-Tasman Radiation Oncology Group undertook a randomized trial comparing the efficacy of a single 8 Gy (8/1) with 20 Gy in 5 fractions (20/5) for this type of pain. ⋯ 8/1 was not shown to be as effective as 20/5, nor was it statistically significantly worse. Outcomes were generally poorer for 8/1, although the quantitative differences were relatively small.
-
Randomized Controlled Trial Clinical Trial
A randomised trial of accelerated radiotherapy for localised invasive bladder cancer.
To evaluate the efficacy and toxicity of an accelerated fractionation regimen to treat localised muscle invasive bladder cancer. ⋯ This accelerated fractionation schedule did not improve on the efficacy of conventional fractionation for patients with T2 and T3 bladder cancer and accelerated fractionation was associated with increased acute bowel reactions.
-
Randomized Controlled Trial Comparative Study Clinical Trial
Double-blind placebo-controlled randomised trial of vitamin E and pentoxifylline in patients with chronic arm lymphoedema and fibrosis after surgery and radiotherapy for breast cancer.
Treatment-induced arm lymphoedema is a common and distressing complication of curative surgery and radiotherapy for early breast cancer. A number of studies testing alpha-tocopherol (vitamin E) and pentoxifylline suggest evidence of clinical regression of superficial radiation-induced fibrosis but there is only very limited evidence from randomised trials. Arm lymphoedema after lymphatic radiotherapy and surgery has been used in the present study as a clinical system for testing these drugs in a double-blind placebo-controlled randomised phase II trial. ⋯ The study fails to demonstrate efficacy of dl-alpha tocopheryl acetate plus pentoxifylline in patients with arm lymphoedema following axillary surgery and lymphatic radiotherapy, nor does it suggest any benefits of these drugs in radiation-induced induration (fibrosis) in the breast, chest wall, pectoral fold, axilla or supraclavicular fossa.
-
Randomized Controlled Trial Comparative Study Clinical Trial
Gastro-intestinal and genito-urinary morbidity after 3D conformal radiotherapy of prostate cancer: observations of a randomized trial.
The late morbidity of a randomized study was analyzed after a follow up of 2 years. The difference in intestinal morbidity was analyzed as a function of the treatment arm and dose volume parameters. The correlation with acute toxicity and (pre-existing) bowel complaints was investigated. ⋯ Conformal radiotherapy at the dose level of 66 Gy does not significantly decrease the incidence of rectal, anal and bladder toxicity compared to conventional radiotherapy. There is a significant relationship between acute and late toxicity and the anal volume exposed to 90% TD. Intestinal (and urological) symptoms at start have a major impact on late toxicity.