title: Phase I trial of gross total resection, permanent iodine-125 brachytherapy, and hyperfractionated radiotherapy for newly diagnosed glioblastoma multiforme.
abstract: OBJECTIVE
  To evaluate the feasibility of gross total resection and permanent I-125 brachytherapy followed by hyperfractionated radiotherapy for patients with newly diagnosed glioblastoma.
  
  
  METHODS
  From April 1999 to May 2002, 21 patients with glioblastoma multiforme were enrolled on a Phase I protocol investigating planned gross total resection and immediate placement of permanent I-125 seeds, followed by postoperative hyperfractionated radiotherapy to a dose of 60 Gy at 100 cGy b.i.d., 5 days per week. Median age and Karnofsky performance status were 50 years (range, 32-65 years) and 90 (range, 70-100), respectively. Toxicity was assessed according to Radiation Therapy Oncology Group criteria.
  
  
  RESULTS
  Eighteen patients completed treatment according to protocol. The median preoperative tumor volume on magnetic resonance imaging was 18.6 cm(3) (range, 4.4-41.2 cm(3)). The median brachytherapy dose measured 5 mm radially outward from the resection cavity was 400 Gy (range, 200-600 Gy). Ten patients underwent 12 reoperations, with 11 of 12 reoperations demonstrating necrosis without evidence of tumor. Because of high toxicity, the study was terminated early. Median progression-free survival and overall survival were 57 and 114 weeks, respectively, but not significantly improved compared with historical patients treated at University of California, San Francisco, with gross total resection and radiotherapy without brachytherapy.
  
  
  CONCLUSIONS
  Treatment with gross total resection and permanent I-125 brachytherapy followed by hyperfractionated radiotherapy as performed in this study results in high toxicity and reoperation rates, without demonstrated improvement in survival.
authors.affiliation: Department of Radiation Oncology, University of California, San Francisco School of Medicine, San Francisco, CA 94143-0226, USA.
authors.forename: Allen M
authors.initials: AM
authors.lastname: Chen
authors.forename: Susan
authors.initials: S
authors.lastname: Chang
authors.forename: Jean
authors.initials: J
authors.lastname: Pouliot
authors.forename: Penny K
authors.initials: PK
authors.lastname: Sneed
authors.forename: Michael D
authors.initials: MD
authors.lastname: Prados
authors.forename: Kathleen R
authors.initials: KR
authors.lastname: Lamborn
authors.forename: Mary K
authors.initials: MK
authors.lastname: Malec
authors.forename: Michael W
authors.initials: MW
authors.lastname: McDermott
authors.forename: Mitchell S
authors.initials: MS
authors.lastname: Berger
authors.forename: David A
authors.initials: DA
authors.lastname: Larson
mesh_terms: D000328:Adult; D000368:Aged; D001918:Brachytherapy / Q000379:methods*; D001932:Brain Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery*; D003131:Combined Modality Therapy / Q000379:methods; D019583:Dose Fractionation, Radiation; D005240:Feasibility Studies; D005909:Glioblastoma / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery*; D006801:Humans; D007457:Iodine Radioisotopes / Q000627:therapeutic use; D008875:Middle Aged; D011446:Prospective Studies; D016019:Survival Analysis; D047368:Tumor Burden
chemical_list: D007457:Iodine Radioisotopes