Palliative Short-course Radiotherapy in Advanced Pelvic Cancer: A Phase II Study (SHARON Project).

AIM: To define safety and efficacy of a palliative, short-course accelerated radiation therapy for symptomatic locally advanced primary pelvic cancer. MATERIALS AND METHODS: A phase II trial was planned based on the minimax Simon's two-stage design. A total of 18 Gy in 4.5 Gy/fraction administered twice a day was delivered (SHARON). Pain and quality of life were recorded according to the Visual Analogue self-assessment and the cancer linear analog scales (CLAS), respectively. RESULTS: Twenty-five patients were enrolled in the study. The most frequent baseline symptoms were pain (48%), bleeding (40%), bleeding/pain (8%), and intestinal sub-occlusion (4%). The overall palliative response rate was 96.0%, with a median palliative duration of 6 months. An improvement of quality-of-life indices (well-being, fatigue, and ability to perform daily activities) was noted in 64.0%, 36.0%, and 48.0% of patients, respectively. CONCLUSION: The SHARON regimen was well tolerated and effective in the palliative treatment of patients with locally advanced pelvic cancer. Based on these results, a multicentric prospective phase III trial is ongoing to compare this regimen with traditional 2-week radiotherapy treatment.

Definition of fields margins for the optimized 2D radiotherapy of prostate carcinoma.

Prostate cancer (PCa) is one of the most common malignancies in men both in western and developing countries. Radiotherapy (RT) is an important therapeutic option. New technologies (including 3D, intensity modulated RT, image-guided RT and, volumetric modulated arc therapy) have been introduced in the last few decades with progressive improvement of clinical outcomes. However, in many developing countries, the only treatment option is the traditional two-dimensional (2D) technique based on standard simulation. The guidelines for 2D field definition are still based on expert's opinions. The aim of the present study was to propose new practical guidelines for 2D fields definition based on 3D simulation in PCa. A total of 20 patients were enrolled. Computed tomography-simulation and pelvic magnetic resonance images were merged to define the prostate volumes. Clinical Target Volume (CTV) was defined using the European Organisation for Research and Treatment of Cancer guidelines in consideration of the four risk categories: Low, intermediate, and high risk with or without seminal vesicles involvement, respectively. Planning Target Volume (PTV) was defined by adding 10 mm to the CTV. For each category, two treatment plans were calculated using a cobalt source or 10 MV photons. Progressive optimization was achieved by evaluating 3D dose distribution. Finally, the optimal distances between field margins and radiological landmarks (bones and rectum with contrast medium) were defined. The results were reported in tabular form. Both field margins (PTV D98% >95%) needed to adequately irradiate all patients and to achieve a similar result in 95% of the enrolled patients are reported. Using a group of patients with PCa and based on a 3D planning analysis, we propose new practical guidelines for PCa 2D-RT based on current criteria for risk category and CTV, and PTV definition.