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Phase I trials involving radiation therapy, quantifying the risks.

Yaacov Richard Lawrence1, Charles Glass, Zvi Symon

  • 1Department of Radiation Oncology, Kimmel Cancer Center, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania, USA; Center for Translational Research in Radiation Oncology, Department of Radiation Oncology, Sheba Medical Center, Tel HaShomer, Israel.

Journal of Medical Imaging and Radiation Oncology
|November 29, 2013
PubMed
Summary
This summary is machine-generated.

Phase I radiation therapy (RT) trials show significant risks of major toxicity, with higher rates in chemotherapy combinations and head-and-neck cancers. While fatal toxicity is rare, careful patient selection is crucial for RT clinical trials.

Keywords:
clinical trialdrug toxicityneoplasmsphase Iradiation oncologyradiation-sensitizing agents

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Area of Science:

  • Oncology
  • Clinical Trials
  • Radiation Oncology

Background:

  • Radiation therapy (RT) is a common cancer treatment, used by over a third of patients.
  • Phase I clinical trials are crucial for evaluating new cancer treatments.
  • Assessing toxicity risks in RT-based phase I trials is essential for patient safety.

Purpose of the Study:

  • To quantify the risks of toxicity for patients enrolled in phase I trials involving radiation therapy.
  • To identify factors associated with increased toxicity in these trials.

Main Methods:

  • Systematic review of English-language phase I and I/II clinical trials involving RT published between 2001 and 2010.
  • Analysis focused on trials from 2001, 2005, and 2009.
  • Calculation of a 'toxicity ratio' (grade 3/4/5 events per patient) and use of linear regression to identify associated variables.

Main Results:

  • A total of 98 trials with 2994 patients were analyzed, revealing 33 treatment-related deaths and 1812 acute grade 3/4 toxicities.
  • The median toxicity ratio across all trials was 0.46.
  • Higher toxicity ratios were significantly associated with concurrent chemotherapy (P=.002) and head-and-neck cancers (P<.001).

Conclusions:

  • While the risk of fatal (grade 5) toxicity is low, significant risks of major toxicity exist in phase I RT trials.
  • Toxicity risks in phase I RT trials are comparable to those in phase I non-RT trials.
  • Chemotherapy and specific cancer types (head-and-neck) are linked to increased toxicity in RT trials.