Radiation therapy quality control in a clinical trial of adjuvant postoperative treatment for rectal cancer

James A. Martenson, Rodolfo Urias, Stephen R. Smalley, Lawrence R. Coia, Joel E. Tepper, Marvin Rotman, Tyvin A. Rich, Michael J. O'Connell

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Purpose: Deviations from protocol can detract from the reliability of results obtained in prospective clinical trials. In an effort to decrease the number of deviations in a prospective trial of adjuvant treatment for rectal cancer, we undertook pretreatment review of the irradiated fields. Methods and Materials: Before initiation of radiation therapy, patients' radiation therapy fields were simulated by their radiation oncologists and films were submitted for review. The treating physicians were then informed whether their fields were in compliance with the protocol or whether any modifications were needed. Results: Among the 625 patients participating in this study who received radiation therapy as a component of protocol treatment, 419 (67%) had no radiation therapy deviations, 127 (20%) had minor deviations, and 51 (8%) had major deviations; 28 (4%) could not be evaluated or did not receive protocol treatment because of circumstances eyond the treating radiation oncologist's control. The pretreatment quality control review identified major deviations in the radiation portals for 57 cases; these findings were communicated to the radiation oncologists prior to initiation of treatment, and, on final review, 40 had no deviation or only minor deviation. Conclusion: In the absence of pretreatment quality control review, 40 additional patients would have had major deviations from their radiation therapy protocol. On the basis of these findings, it is estimated that pretreatment quality control reduced the rate of major deviation from 15% to 8%. Pretreatment review of radiation therapy parameters is an effective method of reducing the frequency of major deviations in prospective clinical trials.

Original languageEnglish (US)
Pages (from-to)51-55
Number of pages5
JournalInternational Journal of Radiation Oncology, Biology, Physics
Volume32
Issue number1
DOIs
StatePublished - Apr 30 1995
Externally publishedYes

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Rectal Neoplasms
quality control
Quality Control
radiation therapy
Radiotherapy
cancer
Clinical Trials
deviation
pretreatment
Clinical Protocols
Therapeutics
Guideline Adherence
radiation
Reproducibility of Results
Radiation
Physicians
physicians
Radiation Oncologists

Keywords

  • Adjuvant therapy
  • Quality control
  • Rectal cancer

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Radiation

Cite this

Radiation therapy quality control in a clinical trial of adjuvant postoperative treatment for rectal cancer. / Martenson, James A.; Urias, Rodolfo; Smalley, Stephen R.; Coia, Lawrence R.; Tepper, Joel E.; Rotman, Marvin; Rich, Tyvin A.; O'Connell, Michael J.

In: International Journal of Radiation Oncology, Biology, Physics, Vol. 32, No. 1, 30.04.1995, p. 51-55.

Research output: Contribution to journalArticle

Martenson, James A. ; Urias, Rodolfo ; Smalley, Stephen R. ; Coia, Lawrence R. ; Tepper, Joel E. ; Rotman, Marvin ; Rich, Tyvin A. ; O'Connell, Michael J. / Radiation therapy quality control in a clinical trial of adjuvant postoperative treatment for rectal cancer. In: International Journal of Radiation Oncology, Biology, Physics. 1995 ; Vol. 32, No. 1. pp. 51-55.
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abstract = "Purpose: Deviations from protocol can detract from the reliability of results obtained in prospective clinical trials. In an effort to decrease the number of deviations in a prospective trial of adjuvant treatment for rectal cancer, we undertook pretreatment review of the irradiated fields. Methods and Materials: Before initiation of radiation therapy, patients' radiation therapy fields were simulated by their radiation oncologists and films were submitted for review. The treating physicians were then informed whether their fields were in compliance with the protocol or whether any modifications were needed. Results: Among the 625 patients participating in this study who received radiation therapy as a component of protocol treatment, 419 (67{\%}) had no radiation therapy deviations, 127 (20{\%}) had minor deviations, and 51 (8{\%}) had major deviations; 28 (4{\%}) could not be evaluated or did not receive protocol treatment because of circumstances eyond the treating radiation oncologist's control. The pretreatment quality control review identified major deviations in the radiation portals for 57 cases; these findings were communicated to the radiation oncologists prior to initiation of treatment, and, on final review, 40 had no deviation or only minor deviation. Conclusion: In the absence of pretreatment quality control review, 40 additional patients would have had major deviations from their radiation therapy protocol. On the basis of these findings, it is estimated that pretreatment quality control reduced the rate of major deviation from 15{\%} to 8{\%}. Pretreatment review of radiation therapy parameters is an effective method of reducing the frequency of major deviations in prospective clinical trials.",
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