Literature DB >> 18362066

Identification of factors limiting patient recruitment into phase I trials: a study from the Royal Marsden Hospital.

Vasilios Karavasilis1, Laurence Digue, Tobias Arkenau, David Eaton, Sarah Stapleton, Johann de Bono, Ian Judson, Stan Kaye.   

Abstract

AIM: To identify factors that may prevent or delay patients referred for consideration of phase I studies from commencing such a study.
METHODS: A retrospective audit of phase I study referrals for the period 1st March to 31st August 2005 to the Drug Development Unit was performed. All reasons that led to either delay or recruitment failure were documented and analysed.
RESULTS: Data from 176 patients (105M/71F) were analysed. Median age at referral was 59 years and median performance status (PS) was 1. Of these, 56 (32%) were successfully recruited in a phase I trial. The median time from trial allocation to commencement of treatment was 4.8 weeks. Poor or deteriorating PS was the reason for delay or recruitment failure in 43 (35%) of non-recruited patients.
CONCLUSIONS: Poor or deteriorating PS was the most common factor limiting accrual to phase I trials. Better patients' selection on this basis might improve recruitment rates.

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Year:  2008        PMID: 18362066     DOI: 10.1016/j.ejca.2008.02.040

Source DB:  PubMed          Journal:  Eur J Cancer        ISSN: 0959-8049            Impact factor:   9.162


  13 in total

1.  Referrals to a Phase I Clinic and Trial Enrollment in the Molecular Screening Era.

Authors:  Tira Tan; Michael Rheaume; Lisa Wang; Helen Chow; Anna Spreafico; Aaron R Hansen; Albiruni R A Razak; Lillian L Siu; Philippe L Bedard
Journal:  Oncologist       Date:  2019-03-04

2.  Nomogram to predict cycle-one serious drug-related toxicity in phase I oncology trials.

Authors:  David M Hyman; Anne A Eaton; Mrinal M Gounder; Gary L Smith; Erika G Pamer; Martee L Hensley; David R Spriggs; Percy Ivy; Alexia Iasonos
Journal:  J Clin Oncol       Date:  2014-01-13       Impact factor: 44.544

3.  Participation and survival of geriatric patients in Phase I clinical trials: the Karmanos Cancer Institute (KCI) experience.

Authors:  Syed F Zafar; Lance K Heilbrun; Prakash Vishnu; Pallavi Jasti; Raghu Venkatramanamoorthy; Li Ding; Patricia M Lorusso; Elisabeth I Heath
Journal:  J Geriatr Oncol       Date:  2011-01-01       Impact factor: 3.599

4.  Evaluation of patient enrollment in oncology phase I clinical trials.

Authors:  Diane A J van der Biessen; Merlijn A Cranendonk; Gaia Schiavon; Bronno van der Holt; Erik A C Wiemer; Ferry A L M Eskens; Jaap Verweij; Maja J A de Jonge; Ron H J Mathijssen
Journal:  Oncologist       Date:  2013-02-21

5.  Early-phase clinical trials in the community: results from the national cancer institute community cancer centers program early-phase working group baseline assessment.

Authors:  Howard A Zaren; Suresh Nair; Ronald S Go; Rebecca A Enos; Keith S Lanier; Michael A Thompson; Jinxiu Zhao; Deborah L Fleming; John C Leighton; Thomas E Gribbin; Donna M Bryant; Angela Carrigan; Jennifer C Corpening; Kimberly A Csapo; Eileen P Dimond; Christie Ellison; Maria M Gonzalez; Jodi L Harr; Kathy Wilkinson; Andrea M Denicoff
Journal:  J Oncol Pract       Date:  2013-03       Impact factor: 3.840

6.  The bottleneck effect in lung cancer clinical trials.

Authors:  Luis E Gonzalez; Steven K Sutton; Christie Pratt; Matthew Gilbertson; Scott Antonia; Gwendolyn P Quinn
Journal:  J Cancer Educ       Date:  2013-09       Impact factor: 2.037

Review 7.  Global trends in the distribution of cancer types among patients in oncology phase I trials, 1991-2015.

Authors:  Kota Itahashi; Toshio Shimizu; Takafumi Koyama; Shunsuke Kondo; Yutaka Fujiwara; Noboru Yamamoto
Journal:  Invest New Drugs       Date:  2018-08-07       Impact factor: 3.850

8.  Early mortality and overall survival in oncology phase I trial participants: can we improve patient selection?

Authors:  Nicole G Chau; Ana Florescu; Kelvin K Chan; Lisa Wang; Eric X Chen; Philippe Bedard; Amit M Oza; Lillian L Siu
Journal:  BMC Cancer       Date:  2011-10-05       Impact factor: 4.430

9.  An inflammation based score can optimize the selection of patients with advanced cancer considered for early phase clinical trials.

Authors:  David J Pinato; Chara Stavraka; Michael J Flynn; Martin D Forster; Séan M O'Cathail; Michael J Seckl; Rebecca S Kristeleit; David Olmos; Samantha J Turnbull; Sarah P Blagden
Journal:  PLoS One       Date:  2014-01-07       Impact factor: 3.240

10.  Clinical Predictors of Early Trial Discontinuation for Patients Participating in Phase I Clinical Trials in Oncology.

Authors:  Joeri A J Douma; Laurien M Buffart; Ramy Sedhom; Mariette Labots; Willemien C Menke-van der Houven van Oordt; Mikkjal Skardhamar; Anthony De Felice; Esther Lee; Divya Dharmaraj; Nilofer S Azad; Michael A Carducci; Henk M W Verheul
Journal:  Cancers (Basel)       Date:  2021-05-11       Impact factor: 6.639

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