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Title: Short-Course Accelerated Radiotherapy in Palliative Treatment of Advanced Pelvic Malignancies: A Phase I Study

Purpose: To define the maximum tolerated dose of a conformal short-course accelerated radiotherapy in patients with symptomatic advanced pelvic cancer. Methods and Materials: A phase I trial in 3 dose-escalation steps was designed: 14 Gy (3.5-Gy fractions), 16 Gy (4-Gy fractions), and 18 Gy (4.5-Gy fractions). The eligibility criteria included locally advanced and/or metastatic pelvic cancer and Eastern Cooperative Oncology Group performance status of {<=}3. Treatment was delivered in 2 days with twice-daily fractionation and at least an 8-hour interval. Patients were treated in cohorts of 6-12 to define the maximum tolerated dose. The dose-limiting toxicity was defined as any acute toxicity of grade 3 or greater, using the Radiation Therapy Oncology Group scale. Pain was recorded using a visual analog scale. The effect on quality of life was evaluated according to Cancer Linear Analog Scale (CLAS). Results: Of the 27 enrolled patients, 11 were male and 16 were female, with a median age of 72 years (range 47-86). The primary tumor sites were gynecologic (48%), colorectal (33.5%), and genitourinary (18.5%). The most frequent baseline symptoms were bleeding (48%) and pain (33%). Only grade 1-2 acute toxicities were recorded. No patients experienced dose-limiting toxicity. With a median follow-up time ofmore » 6 months (range 3-28), no late toxicities were observed. The overall (complete plus partial) symptom remission was 88.9% (95% confidence interval 66.0%-97.8%). Five patients (41.7%) had complete pain relief, and six (50%) showed >30% visual analog scale reduction. The overall response rate for pain was 91.67% (95% confidence interval 52.4%-99.9%). Conclusions: Conformal short course radiotherapy in twice-daily fractions for 2 consecutive days was well tolerated up to a total dose of 18 Gy. A phase II study is ongoing to confirm the efficacy on symptom control and quality of life indexes.« less
Authors:
 [1] ;  [2] ;  [1] ;  [3] ; ; ;  [1] ; ;  [4] ;  [5] ;  [6] ;  [7] ;
  1. Department of Radiation Oncology, Fondazione di Ricercae Cura 'Giovanni Paolo II,' Universita Cattolica del S. Cuore, Campobasso (Italy)
  2. Department of Radiation Oncology, Lacks Cancer Center Saint Mary's Health Care, Grand Rapids, MI (United States)
  3. Department of Gynecologic Oncology, Fondazione di Ricercae Cura 'Giovanni Paolo II,' Universita Cattolica del S. Cuore, Campobasso (Italy)
  4. Department of Palliative Therapies, Fondazione di Ricercae Cura 'Giovanni Paolo II,' Universita Cattolica del S. Cuore, Campobasso (Italy)
  5. Department of Anaesthesia, Intensive Care, and Pain Medicine, Fondazione di Ricercae Cura 'Giovanni Paolo II,' Universita Cattolica del S. Cuore, Campobasso (Italy)
  6. 'Madre Teresa di Calcutta' Hospice, Larino (Italy)
  7. Department of Radiation Oncology, 'San Francesco' Hospital, Nuoro (Italy)
Publication Date:
OSTI Identifier:
22149401
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 83; Journal Issue: 5; Other Information: Copyright (c) 2012 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; METASTASES; NEOPLASMS; PAIN; PATIENTS; RADIATION DOSES; RADIOTHERAPY; STANDARD OF LIVING; TOXICITY