title: Phase I study of accelerated conformal radiotherapy for stage I non-small-cell lung cancer in patients with pulmonary dysfunction: CALGB 39904.
abstract: OBJECTIVE
  The optimal treatment for medically inoperable stage I non-small-cell lung cancer (NSCLC) has not been defined.
  
  
  METHODS
  Cancer and Leukemia Group B trial 39904 prospectively assessed accelerated, once-daily, three-dimensional radiotherapy for early-stage NSCLC. The primary objectives were to define the maximally accelerated course of conformal radiotherapy and to describe the short-term and long-term toxicity of therapy. Entry was limited to patients with clinical stage T1N0 or T2N0 NSCLC (< 4 cm) and pulmonary dysfunction. The nominal total radiotherapy dose remained at 70 Gy, while the number of daily fractions in each successive cohort was reduced.
  
  
  RESULTS
  Thirty-nine eligible patients were accrued (eight patients each on cohorts 1 to 4 and seven patients on cohort 5) between January 2001 and July 2005. One grade 3 nonhematologic toxicity was observed in both cohort 3 (dyspnea) and cohort 4 (pain). The major response rate was 77%. After a median follow-up time of 53 months, the actuarial median survival time of all eligible patients was 38.5 months. Local relapse was observed in three patients.
  
  
  CONCLUSIONS
  Accelerated conformal radiotherapy was well tolerated in a high-risk population with clinical stage I NSCLC. Outcomes are comparable to prospective reports of alternative therapies, including stereotactic body radiation therapy and limited resection, with less apparent severe toxicity. Further investigation of this approach is warranted.
authors.affiliation: Department of Radiation Oncology, State University of New York Upstate Medical University, 750 E Adams St, Syracuse NY 13210, USA. bogartj@upstate.edu
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Bogart
authors.forename: Lydia
authors.initials: L
authors.lastname: Hodgson
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Seagren
authors.forename: A William
authors.initials: AW
authors.lastname: Blackstock
authors.forename: Xiaofei
authors.initials: X
authors.lastname: Wang
authors.forename: Robert
authors.initials: R
authors.lastname: Lenox
authors.forename: Andrew T
authors.initials: AT
authors.lastname: Turrisi
authors.forename: John
authors.initials: J
authors.lastname: Reilly
authors.forename: Ajeet
authors.initials: A
authors.lastname: Gajra
authors.forename: Everett E
authors.initials: EE
authors.lastname: Vokes
authors.forename: Mark R
authors.initials: MR
authors.lastname: Green
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000150:complications / Q000532:radiotherapy*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008171:Lung Diseases / Q000150:complications*; D008175:Lung Neoplasms / Q000150:complications / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D011879:Radiotherapy Dosage; D020266:Radiotherapy, Conformal / Q000379:methods*