Why performance status? A case for alternative functional assessments in pediatric oncology clinical trials

Cancer ◽  
2021 ◽  
Author(s):  
Angela Steineck ◽  
Abby R. Rosenberg
Keyword(s):  
Clinical Trials ◽  
Pediatric Oncology ◽  
Performance Status ◽  
Functional Assessments ◽  
Oncology Clinical Trials

scholarly journals Parental perceptions of the informed consent process in pediatric oncology clinical trials

2013 ◽  
Vol 3 (11) ◽  
Author(s):  
Yvonne D Hastings ◽  
Natalie K Bradford ◽  
Liane R Lockwood ◽  
Robert S Ware ◽  
Jeanine Young
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Pediatric Oncology ◽  
Parental Perceptions ◽  
Informed Consent Process ◽  
Consent Process ◽  
Oncology Clinical Trials

Challenges in incentivizing the pharmaceutical industry to supporting pediatric oncology clinical trials

2013 ◽  
Vol 3 (2) ◽  
pp. 101-103 ◽  
Author(s):  
Paola Angelini ◽  
Kathryn Pritchard-Jones ◽  
Darren R Hargrave
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Pediatric Oncology ◽  
Oncology Clinical Trials

Attrition rates, reasons, and predictive factors in supportive/palliative oncology clinical trials at a comprehensive cancer center.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9069-9069
Author(s):  
Isabella Claudia Glitza ◽  
David Hui ◽  
Gary B. Chisholm ◽  
Eduardo Bruera
Keyword(s):  
Clinical Trials ◽  
Performance Status ◽  
Multivariate Logistic Regression Analysis ◽  
Symptom Burden ◽  
Attrition Rate ◽  
Comprehensive Cancer Center ◽  
Gastrointestinal Malignancies ◽  
Factors Associated ◽  
Palliative Oncology ◽  
Oncology Clinical Trials

9069 Background: Attrition is common among supportive/palliative oncology clinical trials. Few studies have documented the reasons and predictors for dropout. We aimed to determine the rate, reasons and factors associated with attrition both before reaching the primary endpoint (PE) and the end of study (EOS). Methods: We conducted a review of all prospective interventional supportive/palliative oncology trials by our department between 1999-2010. Patient and study characteristics and attrition data were extracted. We determined factors associated with attrition using multivariate logistic regression analysis. Results: 15 blinded randomized trials and 3 single arm trials were included. 16 of 18 studies did not reach accrual target. Baseline demographics for the 1214 patients were: median age 60 (range 23-93 years), female 56%, Caucasians 69%, ECOG performance status ≥3 41%, gastrointestinal malignancies (23%), median fatigue 7/10, appetite 5/10 and pain 4/10. Attrition rate was 26% (N=311) for PE and 44% (N=535) for EOS. Common reasons for EOS dropout were patient preference (N=93, 17%), symptom burden (N=87, 16%), death (N=45, 8%) and hospital admission (N=43, 8%), and were similar for PE dropouts. No predictors were identified for PE attrition. The Table shows poor performance status, anorexia and dyspnea are associated with EOS attrition in multivariate analysis. Conclusions: We found that attrition rate was high amongsupportive/palliative oncology clinical trials, and was associated with poor function and high baseline symptom burden. These findings have implications for future study designs including eligibility criteria and sample size calculation. [Table: see text]

PCN210 Patient-Reported Outcomes in Commercial Pediatric Oncology Clinical Trials

2021 ◽  
Vol 24 ◽  
pp. S59
Author(s):  
M. Murugappan ◽  
B.L. King-Kallimanis ◽  
G.H. Reaman ◽  
V. Bhatnagar ◽  
E.G. Horodniceanu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pediatric Oncology ◽  
Patient Reported Outcomes ◽  
Patient Reported ◽  
Oncology Clinical Trials

scholarly journals Predictors of Success of Phase II Pediatric Oncology Clinical Trials

2019 ◽  
Vol 24 (8) ◽  
Author(s):  
Laura Franshaw ◽  
Maria Tsoli ◽  
Jennifer Byrne ◽  
Chelsea Mayoh ◽  
Siva Sivarajasingam ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase Ii ◽  
Pediatric Oncology ◽  
Predictors Of Success ◽  
Oncology Clinical Trials

scholarly journals Assessment of adherence and relative dose intensity with oral chemotherapy in oncology clinical trials at an academic medical center

2017 ◽  
Vol 24 (5) ◽  
pp. 348-353 ◽  
Author(s):  
Jeff A Engle ◽  
Anne M Traynor ◽  
Toby C Campbell ◽  
Kari B Wisinski ◽  
Noelle LoConte ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Center ◽  
Performance Status ◽  
Academic Medical Center ◽  
Dose Intensity ◽  
Oral Chemotherapy ◽  
Relative Dose Intensity ◽  
Cancer Center ◽  
Related Factors ◽  
Oncology Clinical Trials

Background/Aims Oral chemotherapy is increasingly utilized leaving the patient responsible for self-administering an often complex regimen where adverse effects are common. Non-adherence and reduced relative dose intensity are both associated with poorer outcomes in the community setting but are rarely reported in clinical trials. The purpose of this study is to quantify adherence and relative dose intensity in oncology clinical trials and to determine patient and study related factors that influence adherence and relative dose intensity. Methods Patients were identified from non-industry-funded clinical trials conducted between 1 January 2009 and 31 March 2013 at the University of Wisconsin Carbone Cancer Center. Data were extracted from primary research records. Descriptive statistics and linear regression modeling was performed using SAS 9.4. Results A total of 17 clinical trials and 266 subjects were included. Mean adherence was greater than 97% for the first eight cycles. Mean relative dose intensity was less than 90% for the first cycle and declined over time. Male gender, a performance status of 1 or 2, metastatic disease, and traveling more than 90 miles to reach the cancer center were associated with higher relative dose intensity. Conclusions Patients with cancer enrolled in clinical trials are highly adherent but unlikely to achieve protocol specified relative dose intensity. Given that determining the phase II dose is the primary endpoint of phase I trials, incorporating relative dose intensity into this determination should be considered.

Treatment profiles in patients with cancer aged 80 years or more

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19620-19620
Author(s):  
A. M. Noonan ◽  
A. M. Horgan ◽  
L. Grogan ◽  
O. S. Breathnach
Keyword(s):  
Clinical Trials ◽  
Cancer Treatment ◽  
Cancer Diagnosis ◽  
Treatment Plan ◽  
Performance Status ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Very Elderly ◽  
Patients With Cancer ◽  
Oncology Clinical Trials

19620 Background: There is much criticism about the omission of very elderly patients (>80 years old) from clinical trials. The question is raised as to whether results of clinical trials performed with younger pts (usually <75 years) can be extrapolated to the very elderly population. The most recent Irish census predicts that those aged =80 yrs is set to rise dramatically from the 2001 level of 98,000 to a projected 323,000 in 2036. Accordingly oncologists will have to plan carefully to appropriately treat these pts. Methods: A retrospective review of all new pts referrals aged =80 years was performed for the period Sept. 2005 to Sept. 2006. Pts records were analysed for age, cancer diagnosis, co-morbidities, treatment plan and complications. Results: A total of 52 referrals were identified but records were available for only 49 pts. The average age was 83.7 years (80–93yrs). The M:F ratio was 1.04:1. The 4 most common cancers were Colorectal (20%), lung (18%), oesophageal (12%) and breast (10%). The mean number of co-morbidities was 5. 13 pts (26%) had a previous unrelated cancer diagnosis. 19 patients (38.8%) received cancer treatment (see table ). Three other pts were offered chemotherapy but declined citing age and fear of side effects as their reasons. 68% of patients receiving cancer treatment had a performance status (PS) of ECOG =1. The main reasons cited for not giving cancer treatment were poor PS (21), comorbidities (13), or patient preference (3). 75% of patients receiving chemotherapy were on schedule with no delays. Only 25% (2) of patients experienced delays due to toxicity. Conclusion: In this diverse group of very elderly cancer pts, those that received cancer treatment tolerated it reasonably well. However, 55% of pts were deemed unfit for cancer treatment at presentation due to poor performance status or compromising co-morbidities. This fact must be taken into account when setting recruitment targets for this age group when planning oncology clinical trials. No significant financial relationships to disclose. [Table: see text]

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