title: Short-course accelerated radiotherapy in palliative treatment of advanced pelvic malignancies: a phase I study.
abstract: OBJECTIVE
  To define the maximum tolerated dose of a conformal short-course accelerated radiotherapy in patients with symptomatic advanced pelvic cancer.
  
  
  METHODS
  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 of 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.
authors.affiliation: Department of Radiation Oncology, Fondazione di Ricercae Cura "Giovanni Paolo II," Università Cattolica del S. Cuore, Campobasso, Italy.
authors.forename: Luciana
authors.initials: L
authors.lastname: Caravatta
authors.forename: Gilbert D A
authors.initials: GD
authors.lastname: Padula
authors.forename: Gabriella
authors.initials: G
authors.lastname: Macchia
authors.forename: Gabriella
authors.initials: G
authors.lastname: Ferrandina
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Bonomo
authors.forename: Francesco
authors.initials: F
authors.lastname: Deodato
authors.forename: Mariangela
authors.initials: M
authors.lastname: Massaccesi
authors.forename: Samantha
authors.initials: S
authors.lastname: Mignogna
authors.forename: Rosa
authors.initials: R
authors.lastname: Tambaro
authors.forename: Marco
authors.initials: M
authors.lastname: Rossi
authors.forename: Mariano
authors.initials: M
authors.lastname: Flocco
authors.forename: Andrea
authors.initials: A
authors.lastname: Scapati
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
authors.forename: Fabio
authors.initials: F
authors.lastname: Pacelli
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Valentini
authors.forename: Numa
authors.initials: N
authors.lastname: Cellini
authors.forename: Alessio G
authors.initials: AG
authors.lastname: Morganti
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D019583:Dose Fractionation, Radiation; D005260:Female; D005833:Genital Neoplasms, Female / Q000000981:diagnostic imaging / Q000473:pathology / Q000532:radiotherapy; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010147:Pain Measurement / Q000379:methods; D010166:Palliative Care / Q000379:methods*; D010386:Pelvic Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000532:radiotherapy*; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000532:radiotherapy; D011788:Quality of Life; D011832:Radiation Injuries / Q000209:etiology; D011859:Radiography; D011880:Radiotherapy Planning, Computer-Assisted / Q000379:methods; D020266:Radiotherapy, Conformal / Q000009:adverse effects / Q000379:methods*; D012004:Rectal Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000532:radiotherapy; D001749:Urinary Bladder Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000532:radiotherapy