The Missing Pieces in Reporting of Randomized Controlled Trials of External Beam Radiation Therapy Dose Escalation for Prostate Cancer

Nicholas Zaorsky, Brian L. Egleston, Eric M. Horwitz, Adam P. Dicker, Paul L. Nguyen, Timothy N. Showalter, Robert B. Den

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Randomized controlled trials (RCTs) are the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and for assessing the cost-effectiveness of a treatment. For many patients, cancer is a chronic illness; RCTs evaluating treatments for indolent cancers must evolve to facilitate medical decision-making, as "concrete" patient outcomes (eg, survival) will likely be excellent independent of the intervention, and detecting a difference between trial arms may be impossible. In this commentary, we articulate 9 recommendations that we hope future clinical trialists and funding agencies (including those under the National Cancer Institute) will take into consideration when planning RCTs to help guide subsequent interpretation of results and clinical decision making, based on RCTs of external beam radiation therapy dose escalation for the most common indolent cancer in men, that is, prostate cancer. We recommend routinely reporting: (1) race; (2) medical comorbidities; (3) psychiatric comorbidities; (4) insurance status; (5) education; (6) marital status; (7) income; (8) sexual orientation; and (9) facility-related characteristics (eg, number of centers involved, type of facilities, yearly hospital volumes). We discuss how these factors independently affect patient outcomes and toxicities; future clinicians and governing organizations should consider this information to plan RCTs accordingly (to maximize patient accrual and total n), select appropriate endpoints (eg, toxicity, quality of life, sexual function), actively monitor RCTs, and report results so as to identify the optimal treatment among subpopulations.

Original languageEnglish (US)
Pages (from-to)321-326
Number of pages6
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume39
Issue number4
DOIs
StatePublished - Aug 1 2016

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Prostatic Neoplasms
Radiotherapy
Randomized Controlled Trials
Comorbidity
Neoplasms
Insurance Coverage
National Cancer Institute (U.S.)
Marital Status
Sexual Behavior
Cost-Benefit Analysis
Psychiatry
Chronic Disease
Therapeutics
Quality of Life
Organizations
Education
Survival
Clinical Decision-Making

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Zaorsky, Nicholas ; Egleston, Brian L. ; Horwitz, Eric M. ; Dicker, Adam P. ; Nguyen, Paul L. ; Showalter, Timothy N. ; Den, Robert B. / The Missing Pieces in Reporting of Randomized Controlled Trials of External Beam Radiation Therapy Dose Escalation for Prostate Cancer. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 2016 ; Vol. 39, No. 4. pp. 321-326.
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The Missing Pieces in Reporting of Randomized Controlled Trials of External Beam Radiation Therapy Dose Escalation for Prostate Cancer. / Zaorsky, Nicholas; Egleston, Brian L.; Horwitz, Eric M.; Dicker, Adam P.; Nguyen, Paul L.; Showalter, Timothy N.; Den, Robert B.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 39, No. 4, 01.08.2016, p. 321-326.

Research output: Contribution to journalArticle

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