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Continuous hyperfractionated accelerated radiotherapy - Escalated dose (CHART-ED): A phase I study.

Matthew Quintin Fielding Hatton1, Robert Hill2, John David Fenwick3

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Radiotherapy and Oncology : Journal of the European Society for Therapeutic Radiology and Oncology
|December 22, 2015
PubMed
Summary
This summary is machine-generated.

Continuous, Accelerated, Radiotherapy, and Hyperfractionation (CHART) dose escalation is feasible for inoperable non-small cell lung cancer. This study found no dose-limiting toxicities, supporting further trials of escalated CHART schedules.

Keywords:
Continuous Hyper-fractionated Accelerated Radiotherapy – escalated dose (CHART-ED)Inoperable non-small cell lung cancerRadiotherapy

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Area of Science:

  • Radiation Oncology
  • Medical Physics
  • Clinical Oncology

Background:

  • Locally advanced inoperable non-small cell lung cancer (NSCLC) patients may benefit from radical radiotherapy.
  • Continuous, Accelerated, Radiotherapy, and Hyperfractionation (CHART) showed a 9% improvement in 2-year survival compared to conventional radiotherapy.
  • Modern 3D CT-based planning enables dose escalation for conventional and CHART-WeekEndLess (CHARTWEL) schedules.

Purpose of the Study:

  • To assess the feasibility and safety of escalating doses of CHART radiotherapy in patients with inoperable NSCLC.
  • To determine dose-limiting toxicities associated with escalated CHART schedules.

Main Methods:

  • An open-label, phase I dose escalation study enrolled patients with histologically confirmed, inoperable, stage I-III NSCLC (WHO performance status 0-2).
  • Patients were assigned to one of three sequential cohorts receiving escalated doses of CHART radiotherapy.
  • Dose escalation ranged from standard 54 Gy/36f/12 days to 64.8 Gy/42f/17 days.

Main Results:

  • Eighteen patients were enrolled; 17 completed their planned radiotherapy schedules.
  • The median survival across cohorts was 2 years, with 9 deaths observed.
  • Grade 3 or 4 adverse events occurred in 6 patients, but pre-specified dose-limiting toxicities were not observed.

Conclusions:

  • CHART radiotherapy is a viable schedule in the UK, and dose escalation is feasible without dose-limiting toxicities.
  • A dose of 64.8 Gy/42f/17 days is recommended for further clinical trials.
  • A randomized phase II study is planned to confirm safety and select schedules for phase III trials.