Journal ArticleDOI
Patient-Reported Outcomes in Phase II Cancer Clinical Trials: Lessons Learned and Future Directions
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TLDR
It is argued that there is a clear and important role for PRO assessment in phase II trials going forward, and contributions significantly enhance the design of phase III trials, ultimately leading to the efficient utilization of clinical trial resources.Abstract:
With increasing limits on the resources available to conduct cancer clinical trials, the inclusion of patient-reported outcomes (PROs) in treatment and symptom management trials must be prioritized. Although it has been suggested on occasion that phase III trials should take precedence over phase II trials, we argue that there is a clear and important role for PRO assessment in phase II trials going forward. To illustrate the value realized from including PROs in phase II trials, we provide case examples from cancer treatment and supportive care. The benefits of including PROs in symptom management intervention research are exemplified using phase II trials targeting cognitive impairment. The inclusion of PROs in phase II cancer clinical trials adds important information about the impact of treatment in health-related quality of life, and advances the science of PRO measurement. These contributions significantly enhance the design of phase III trials, ultimately leading to the efficient utilization of clinical trial resources.read more
Citations
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Journal ArticleDOI
Bleomycin-Based Electrochemotherapy: Clinical Outcome from a Single Institution’s Experience with 52 Patients
Luca Giovanni Campana,Simone Mocellin,Michela Basso,Oliviero Puccetti,Gian Luca De Salvo,Vanna Chiarion-Sileni,Antonella Vecchiato,Luigi Corti,Carlo Riccardo Rossi,Donato Nitti +9 more
TL;DR: In a palliative setting, ECT proved to be safe, effective in all tumors treated, and useful in preserving patients’ quality of life.
Journal ArticleDOI
Guidelines for the development and incorporation of biomarker studies in early clinical trials of novel agents.
Janet E. Dancey,Kevin K. Dobbin,Susan Groshen,J. Milburn Jessup,Andrew H. Hruszkewycz,Maria Koehler,Ralph E. Parchment,Mark J. Ratain,Lalitha K. Shankar,Walter M. Stadler,Lawrence D. True,Amy E. Gravell,Michael R. Grever +12 more
TL;DR: This document provides standard definitions and categories of biomarkers, and lists recommendations to sponsors and investigators for biomarker incorporation into early drug trials, and provides recommendations for sponsors developing clinical trials with biomarker studies.
Journal ArticleDOI
A global analysis of multitrial data investigating quality of life and symptoms as prognostic factors for survival in different tumor sites
C. Quinten,Francesca Martinelli,Corneel Coens,Mirjam A. G. Sprangers,Jolie Ringash,Carolyn C. Gotay,Kristin Bjordal,Eva Greimel,Bryce B. Reeve,J. Maringwa,Divine E. Ediebah,Efstathios Zikos,Madeleine King,David Osoba,Martin J B Taphoorn,Henning Flechtner,Joseph Schmucker-Von Koch,Joachim Weis,Andrew Bottomley +18 more
TL;DR: The objective of this study was to examine the prognostic value of baseline health‐related quality of life (HRQOL) for survival with regard to different cancer sites using 1 standardized and validated patient self‐assessment tool.
Journal ArticleDOI
The Design of Phase II Clinical Trials Testing Cancer Therapeutics: Consensus Recommendations from the Clinical Trial Design Task Force of the National Cancer Institute Investigational Drug Steering Committee
Lesley Seymour,S. Percy Ivy,Daniel J. Sargent,David R. Spriggs,Laurence H. Baker,Larry Rubinstein,Mark J. Ratain,Michael Le Blanc,David J. Stewart,John Crowley,Susan Groshen,Jeffrey S. Humphrey,Pamela J. West,Donald A. Berry +13 more
TL;DR: The Clinical Trial Design Task Force (CTD-TF) of the National Cancer Institute (NCI) Investigational Drug Steering Committee (IDSC) has published a series of discussion papers on phase II trial design, which encourage the use of progression-free survival as an endpoint, randomization, inclusion of biomarkers, and incorporation of newer designs.
Journal ArticleDOI
Patient-Reported Outcomes Assessment in Cancer Trials: Taking Stock, Moving Forward
Joseph Lipscomb,Bryce B. Reeve,Steven B. Clauser,Jeffrey S. Abrams,Deborah Watkins Bruner,Laurie B. Burke,Andrea Denicoff,Patricia A. Ganz,Kathleen Gondek,Lori M. Minasian,Ann M. O'Mara,Dennis A. Revicki,Edwin P. Rock,Julia H. Rowland,Maria Sgambati,Edward L. Trimble +15 more
TL;DR: This concluding report takes stock of what has been learned to date about the successes and challenges in patient-reported outcome (PRO) assessment in phase III, phase II, and symptom management trials in cancer and identifies ways to improve the scientific soundness, feasibility, and policy relevance of PROs in trials.
References
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Journal ArticleDOI
“Mini-mental state”: A practical method for grading the cognitive state of patients for the clinician
Marshal F. Folstein,Marshal F. Folstein,Susan E B Folstein,Susan E B Folstein,Paul R. McHugh,Paul R. McHugh +5 more
TL;DR: A simplified, scored form of the cognitive mental status examination, the “Mini-Mental State” (MMS) which includes eleven questions, requires only 5-10 min to administer, and is therefore practical to use serially and routinely.
A practical method for grading the cognitive state of patients for the clinician
TL;DR: The Mini-Mental State (MMS) as mentioned in this paper is a simplified version of the standard WAIS with eleven questions and requires only 5-10 min to administer, and is therefore practical to use serially and routinely.
Journal ArticleDOI
Intraperitoneal Cisplatin and Paclitaxel in Ovarian Cancer
Deborah K. Armstrong,Brian N. Bundy,Lari Wenzel,Helen Q. Huang,Rebecca N. Baergen,Shashikant Lele,Larry J. Copeland,Joan L. Walker,Robert A. Burger +8 more
TL;DR: Quality of life was significantly worse in the intraperitoneal-therapy group before cycle 4 and three to six weeks after treatment but not one year after treatment, while survival in patients with optimally debulked stage III ovarian cancer improved.
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