Was it worth it (WIWI)? Patient satisfaction with clinical trial participation: Results from North Central Cancer Treatment Group (NCCTG) phase III trial N0147.

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. 6122-6122 ◽  
Author(s):  
J. A. Sloan ◽  
M. R. Mahoney ◽  
D. J. Sargent ◽  
J. M. Hubbard ◽  
H. Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Patient Satisfaction ◽  
Treatment Group ◽  
Cancer Treatment ◽  
Phase Iii ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
North Central ◽  
Phase Iii Trial

scholarly journals Associations Between Cigarette Smoking Status and Colon Cancer Prognosis Among Participants in North Central Cancer Treatment Group Phase III Trial N0147

2013 ◽  
Vol 31 (16) ◽  
pp. 2016-2023 ◽  
Author(s):  
Amanda I. Phipps ◽  
Qian Shi ◽  
Polly A. Newcomb ◽  
Garth D. Nelson ◽  
Daniel J. Sargent ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Treatment Group ◽  
Cancer Treatment ◽  
Phase Iii ◽  
Smoking History ◽  
Wild Type ◽  
North Central ◽  
Mutation Status ◽  
Phase Iii Trial ◽  
Time To Recurrence

Purpose By using data from North Central Cancer Treatment Group Phase III Trial N0147, a randomized adjuvant trial of patients with stage III colon cancer, we assessed the relationship between smoking and cancer outcomes, disease-free survival (DFS), and time to recurrence (TTR), accounting for heterogeneity by patient and tumor characteristics. Patients and Methods Before random assignment to infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX) or FOLFOX plus cetuximab, 1,968 participants completed a questionnaire on smoking history and other risk factors. Cox models assessed the association between smoking history and the primary trial outcome of DFS (ie, time to recurrence or death), as well as TTR, adjusting for other clinical and patient factors. The median follow-up was 3.5 years among patients who did not experience events. Results Compared with never-smokers, ever smokers experienced significantly shorter DFS (3-year DFS proportion: 70% v 74%; hazard ratio [HR], 1.21; 95% CI, 1.02 to 1.42). This association persisted after multivariate adjustment (HR, 1.23; 95% CI, 1.02 to 1.49). There was significant interaction in this association by BRAF mutation status (P = .03): smoking was associated with shorter DFS in patients with BRAF wild-type (HR, 1.36; 95% CI, 1.11 to 1.66) but not BRAF mutated (HR, 0.80; 95% CI, 0.50 to 1.29) colon cancer. Smoking was more strongly associated with poorer DFS in those with KRAS mutated versus KRAS wild-type colon cancer (HR, 1.50 [95% CI, 1.12 to 2.00] v HR, 1.09 [95% CI, 0.85 to 1.39]), although interaction by KRAS mutation status was not statistically significant (P = .07). Associations were comparable in analyses of TTR. Conclusion Overall, smoking was significantly associated with shorter DFS and TTR in patients with colon cancer. These adverse relationships were most evident in patients with BRAF wild-type or KRAS mutated colon cancer.

scholarly journals Alcohol consumption and colon cancer prognosis among participants in north central cancer treatment group phase III trial N0147

2016 ◽  
Vol 139 (5) ◽  
pp. 986-995 ◽  
Author(s):  
Amanda I. Phipps ◽  
Qian Shi ◽  
Paul J. Limburg ◽  
Garth D. Nelson ◽  
Daniel J. Sargent ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Treatment Group ◽  
Alcohol Consumption ◽  
Cancer Treatment ◽  
Cancer Prognosis ◽  
Phase Iii ◽  
North Central ◽  
Phase Iii Trial

scholarly journals Evaluation of the Value of Attribution in the Interpretation of Adverse Event Data: A North Central Cancer Treatment Group and American College of Surgeons Oncology Group Investigation

2010 ◽  
Vol 28 (18) ◽  
pp. 3002-3007 ◽  
Author(s):  
Shauna L. Hillman ◽  
Sumithra J. Mandrekar ◽  
Brian Bot ◽  
Ronald P. DeMatteo ◽  
Edith A. Perez ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Treatment Group ◽  
Cancer Treatment ◽  
Randomized Clinical Trials ◽  
Study Drug ◽  
Phase Iii ◽  
Oncology Group ◽  
North Central ◽  
American College Of Surgeons ◽  
Group Trial

Purpose In March 1998, Common Toxicity Criteria (CTC) version 2.0 introduced the collection of attribution of adverse events (AEs) to study drug. We investigate whether attribution adds value to the interpretation of AE data. Patients and Methods Patients in the placebo arm of two phase III trials—North Central Cancer Treatment Group Trial 97-24-51 (carboxyamino-triazole v placebo in advanced non–small-cell lung cancer) and American College of Surgeons Oncology Group Trial Z9001 (imatinib mesylate v placebo after resection of primary gastrointestinal stromal tumors)—were studied. Attribution was categorized as unrelated (not related or unlikely) and related (possible, probable, or definite). Results In total, 398 patients (84 from Trial 97-24-51 and 314 from Trial Z9001) and 7,736 AEs were included; 47% and 50% of the placebo-arm AEs, respectively, were reported as related. When the same AE was reported in the same patient on multiple visits, the attribution category changed at least once 36% and 31% of the time. AE type and sex (Trial Z9001) and AE type and performance status (Trial 97-24-51) were associated with a higher likelihood of AEs being deemed related. Conclusion Nearly 50% of AEs were reported as attributed to study drug on the placebo arm of two randomized clinical trials. These data provide strong evidence that AE attribution is difficult to determine, unreliable, and of questionable value in interpreting AE data in randomized clinical trials.

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