Skip to main content
Journal cover image

Compliance with therapeutic guidelines in Radiation Therapy Oncology Group prospective gastrointestinal clinical trials.

Publication ,  Journal Article
Willett, CG; Moughan, J; O'Meara, E; Galvin, JM; Crane, CH; Winter, K; Manfredi, D; Rich, TA; Rabinovitch, R; Lustig, R; Machtay, M; Curran, WJ
Published in: Radiother Oncol
October 2012

BACKGROUND: This report analyzes the adherence to radiation therapy protocol guidelines in contemporary Radiation Therapy Oncology Group (RTOG) gastrointestinal trials. We aim to provide insight into current standards and compliance of radiation therapy field design and administration. METHODS: From 1994 to 2006, the Gastrointestinal Cancer Committee of the RTOG initiated and completed 15 phase I-III clinical trials utilizing radiation therapy in the multimodality treatment of gastrointestinal cancers. In each protocol, details for planning and executing radiation therapy were outlined and each protocol contained scoring criteria for these components of radiation therapy, characterized according to per-protocol, variation acceptable and deviation unacceptable. Review of treatment planning and implementation was performed in all studies following therapy completion. RESULTS: Radiation therapy planning and implementation was reviewed in 2309 of 2312 (99.9%) patients. The mean rate of compliance over all for the 15 protocols was 65% (total of the 2309 analyzed patients). The mean variation acceptable rate was 21% whereas the mean deviation unacceptable rate was 5%. The mean "other" rate (no RT given or incomplete RT due to death, progression or refusal) was 8%. Two of the 15 trials (13%) had deviation unacceptable rates >10%. In four studies incorporating pre-treatment review of radiation therapy planning and treatment, compliance with protocol therapy was enhanced. CONCLUSIONS: The fidelity of radiation planning and execution detailed in protocol to actual therapy is heterogeneous, with a mean per-protocol rate of 65%. As clinical trials evolve, available technology should permit efficient pre-treatment review processes, thus facilitating compliance to protocol therapy. These analyses should also permit prospective analysis of outcome measures by compliance to therapy.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Radiother Oncol

DOI

EISSN

1879-0887

Publication Date

October 2012

Volume

105

Issue

1

Start / End Page

9 / 13

Location

Ireland

Related Subject Headings

  • Radiotherapy
  • Quality Assurance, Health Care
  • Practice Guidelines as Topic
  • Oncology & Carcinogenesis
  • Humans
  • Gastrointestinal Neoplasms
  • Clinical Trials as Topic
  • 5105 Medical and biological physics
  • 3211 Oncology and carcinogenesis
  • 3202 Clinical sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Willett, C. G., Moughan, J., O’Meara, E., Galvin, J. M., Crane, C. H., Winter, K., … Curran, W. J. (2012). Compliance with therapeutic guidelines in Radiation Therapy Oncology Group prospective gastrointestinal clinical trials. Radiother Oncol, 105(1), 9–13. https://doi.org/10.1016/j.radonc.2012.09.011
Willett, Christopher G., Jennifer Moughan, Elizabeth O’Meara, James M. Galvin, Christopher H. Crane, Kathryn Winter, Denise Manfredi, et al. “Compliance with therapeutic guidelines in Radiation Therapy Oncology Group prospective gastrointestinal clinical trials.Radiother Oncol 105, no. 1 (October 2012): 9–13. https://doi.org/10.1016/j.radonc.2012.09.011.
Willett CG, Moughan J, O’Meara E, Galvin JM, Crane CH, Winter K, et al. Compliance with therapeutic guidelines in Radiation Therapy Oncology Group prospective gastrointestinal clinical trials. Radiother Oncol. 2012 Oct;105(1):9–13.
Willett, Christopher G., et al. “Compliance with therapeutic guidelines in Radiation Therapy Oncology Group prospective gastrointestinal clinical trials.Radiother Oncol, vol. 105, no. 1, Oct. 2012, pp. 9–13. Pubmed, doi:10.1016/j.radonc.2012.09.011.
Willett CG, Moughan J, O’Meara E, Galvin JM, Crane CH, Winter K, Manfredi D, Rich TA, Rabinovitch R, Lustig R, Machtay M, Curran WJ. Compliance with therapeutic guidelines in Radiation Therapy Oncology Group prospective gastrointestinal clinical trials. Radiother Oncol. 2012 Oct;105(1):9–13.
Journal cover image

Published In

Radiother Oncol

DOI

EISSN

1879-0887

Publication Date

October 2012

Volume

105

Issue

1

Start / End Page

9 / 13

Location

Ireland

Related Subject Headings

  • Radiotherapy
  • Quality Assurance, Health Care
  • Practice Guidelines as Topic
  • Oncology & Carcinogenesis
  • Humans
  • Gastrointestinal Neoplasms
  • Clinical Trials as Topic
  • 5105 Medical and biological physics
  • 3211 Oncology and carcinogenesis
  • 3202 Clinical sciences