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Children's International Polyposis (CHIP) study : a randomized, double-blind, placebo-controlled study of celecoxib in children with familial adenomatous polyposis

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Abstract
Objective: To evaluate the efficacy and safety of celecoxib versus placebo in the prevention and treatment of colorectal polyposis in children with familial adenomatous polyposis (FAP). Methods: In this Phase III, double-blind, randomized, placebo-controlled, multicenter trial patients aged 10-17 years with FAP were randomized to celecoxib (16 mg/kg/day) or placebo for up to 5 years. Patients underwent annual assessments, including colonoscopies, to detect the time from randomization to the earliest occurrence of >= 20 polyps (> 2 mm in size) or colorectal malignancy. The study was terminated early due to low rate of observed endpoints combined with a lower than expected enrollment rate. Descriptive results are provided. Results: Of 106 randomized patients, 55 were treated with celecoxib (mean age 12.6 years; 52.7% female) and 51 were given placebo (mean age 12.2 years; 54.9% female). Disease progression (>= 20 polyps, > 2 mm in size) was observed in seven (12.7%) and 13 (25.5%) patients, respectively. The median time to disease progression was 2.1 years in the celecoxib group and 1.1 years for placebo. No patient developed colorectal cancer. The rate of adverse events (AEs) was similar in both groups (75.5% and 72.9%, respectively). Three patients in the celecoxib group (none in the placebo group) experienced serious AEs. Conclusion: In children with FAP, celecoxib was a well-tolerated treatment that was associated with a lower rate of colorectal polyposis and a longer time to disease progression compared with placebo. Due to the low rate of observed endpoints, the long-term impact of these results could not be ascertained.
Keywords
COLORECTAL ADENOMAS, PREVENTION, EXPRESSION, SULINDAC, EFFICACY, SAFETY, FAP, chemoprevention, clinical trial, adenoma, colorectal

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Chicago
Burke, Carol A, Robin Phillips, Manuela F Berger, Chunming Li, Margaret Noyes Essex, Dinu Iorga, Patrick M Lynch, the study site investigators, Catharina Dhooge, and Marc Peeters. 2017. “Children’s International Polyposis (CHIP) Study : a Randomized, Double-blind, Placebo-controlled Study of Celecoxib in Children with Familial Adenomatous Polyposis.” Clinical and Experimental Gastroenterology 10: 177–185.
APA
Burke, C. A., Phillips, R., Berger, M. F., Li, C., Essex, M. N., Iorga, D., Lynch, P. M., et al. (2017). Children’s International Polyposis (CHIP) study : a randomized, double-blind, placebo-controlled study of celecoxib in children with familial adenomatous polyposis. CLINICAL AND EXPERIMENTAL GASTROENTEROLOGY, 10, 177–185.
Vancouver
1.
Burke CA, Phillips R, Berger MF, Li C, Essex MN, Iorga D, et al. Children’s International Polyposis (CHIP) study : a randomized, double-blind, placebo-controlled study of celecoxib in children with familial adenomatous polyposis. CLINICAL AND EXPERIMENTAL GASTROENTEROLOGY. 2017;10:177–85.
MLA
Burke, Carol A, Robin Phillips, Manuela F Berger, et al. “Children’s International Polyposis (CHIP) Study : a Randomized, Double-blind, Placebo-controlled Study of Celecoxib in Children with Familial Adenomatous Polyposis.” CLINICAL AND EXPERIMENTAL GASTROENTEROLOGY 10 (2017): 177–185. Print.
@article{8560303,
  abstract     = {Objective: To evaluate the efficacy and safety of celecoxib versus placebo in the prevention and treatment of colorectal polyposis in children with familial adenomatous polyposis (FAP). 
Methods: In this Phase III, double-blind, randomized, placebo-controlled, multicenter trial patients aged 10-17 years with FAP were randomized to celecoxib (16 mg/kg/day) or placebo for up to 5 years. Patients underwent annual assessments, including colonoscopies, to detect the time from randomization to the earliest occurrence of {\textrangle}= 20 polyps ({\textrangle} 2 mm in size) or colorectal malignancy. The study was terminated early due to low rate of observed endpoints combined with a lower than expected enrollment rate. Descriptive results are provided. 
Results: Of 106 randomized patients, 55 were treated with celecoxib (mean age 12.6 years; 52.7\% female) and 51 were given placebo (mean age 12.2 years; 54.9\% female). Disease progression ({\textrangle}= 20 polyps, {\textrangle} 2 mm in size) was observed in seven (12.7\%) and 13 (25.5\%) patients, respectively. The median time to disease progression was 2.1 years in the celecoxib group and 1.1 years for placebo. No patient developed colorectal cancer. The rate of adverse events (AEs) was similar in both groups (75.5\% and 72.9\%, respectively). Three patients in the celecoxib group (none in the placebo group) experienced serious AEs. 
Conclusion: In children with FAP, celecoxib was a well-tolerated treatment that was associated with a lower rate of colorectal polyposis and a longer time to disease progression compared with placebo. Due to the low rate of observed endpoints, the long-term impact of these results could not be ascertained.},
  author       = {Burke, Carol A and Phillips, Robin and Berger, Manuela F and Li, Chunming and Essex, Margaret Noyes and Iorga, Dinu and Lynch, Patrick M and study site investigators, the and Dhooge, Catharina and Peeters, Marc},
  issn         = {1178-7023},
  journal      = {CLINICAL AND EXPERIMENTAL GASTROENTEROLOGY},
  keyword      = {COLORECTAL ADENOMAS,PREVENTION,EXPRESSION,SULINDAC,EFFICACY,SAFETY,FAP,chemoprevention,clinical trial,adenoma,colorectal},
  language     = {eng},
  pages        = {177--185},
  title        = {Children's International Polyposis (CHIP) study : a randomized, double-blind, placebo-controlled study of celecoxib in children with familial adenomatous polyposis},
  url          = {http://dx.doi.org/10.2147/CEG.S121841},
  volume       = {10},
  year         = {2017},
}

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