N08C9 (Alliance) - A Phase 3 Randomized Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy

2013 ◽  
Vol 87 (5) ◽  
pp. 1186-1187 ◽  
Author(s):  
R.C. Miller ◽  
D.G. Petereit ◽  
J.A. Sloan ◽  
H. Liu ◽  
J.A. Martenson ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Acute Diarrhea ◽  
Randomized Study ◽  
Phase 3 ◽  
Pelvic Radiation

Phase III double-blind study of depot octreotide versus placebo in the prevention of acute diarrhea during pelvic radiation therapy: Results of North Central Cancer Treatment Group protocol N00CA

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8506-8506 ◽  
Author(s):  
J. A. Martenson ◽  
J. A. Sloan ◽  
R. L. Deming ◽  
D. B. Wender ◽  
K. J. Stien ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Treatment Group ◽  
Cancer Treatment ◽  
Randomized Study ◽  
Wilcoxon Test ◽  
Phase Iii ◽  
Double Blind Study ◽  
Double Blind ◽  
North Central ◽  
Pelvic Radiation

8506 Background: A randomized study (Int J Rad Oncol Biol Phys 54:195–202, 2002) demonstrated a beneficial effect for octreotide in the treatment of diarrhea in patients receiving pelvic radiation therapy. This North Central Cancer Treatment Group study was undertaken to determine the effectiveness of depot octreotide in the prevention of diarrhea during pelvic radiation therapy. Methods: Patients receiving pelvic radiation therapy, with a planned minimum dose of 45 Gy at 1.70–2.1 Gy per day, were eligible for this study. The study was designed for a Wilcoxon test, with 112 evaluable patients, to have 85% power to detect a further one grade decrease in diarrhea over and above that experienced by patients treated with placebo. Between June 13, 2002 and October 28, 2005, 120 evaluable patients were randomly allocated, in double blind fashion, to receive octreotide (62 patients) or placebo (58 patients), prior to the fourth radiation therapy fraction. Octreotide dosing: Octreotide, 100 micrograms subcutaneously on day 1 followed by depot octreotide, 20 milligrams intramuscularly on days 2 and 29. Results: Grade 0, 1, 2 and 3 diarrhea was observed in 17%, 32%, 26% and 26% of patients treated with octreotide and 18%, 34%, 22%, and 26% of patients treated with placebo (P=0.86). Grade 0, 1, 2 and 3 tenesmus was observed in 55%, 30%, 11% and 4% of patients treated with octreotide and 76%, 16%, 4%, and 4% of patients treated with placebo (P=0.04). No other statistically significant differences in toxicity were observed. Conclusions: Octreotide, as administered in this study, did not decrease diarrhea during pelvic radiation therapy. [Table: see text]

Phase III Double-Blind Study of Glutamine Versus Placebo for the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy

2003 ◽  
Vol 21 (9) ◽  
pp. 1669-1674 ◽  
Author(s):  
Timothy F. Kozelsky ◽  
Gregory E. Meyers ◽  
Jeff A. Sloan ◽  
Thomas G. Shanahan ◽  
Stephen J. Dick ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Acute Diarrhea ◽  
Bowel Function ◽  
Blind Study ◽  
Phase Iii ◽  
Treatment Quality ◽  
Double Blind Study ◽  
Double Blind ◽  
Pelvic Radiation ◽  
The North

Purpose: A phase III, randomized, double-blind study was conducted by the North Central Cancer Treatment Group to determine the efficacy and toxicity of oral glutamine for the prevention of acute diarrhea in patients receiving pelvic radiation therapy (RT). Patients and Methods: All 129 patients enrolled from 14 institutions between February 1998 and October 1999 were eligible. Patients received 4 g of glutamine or placebo orally, twice a day, beginning with the first or second day of RT and continuing for 2 weeks after RT. During treatment, patients were assessed weekly for toxicity, and a bowel function questionnaire was administered. The primary measures of treatment efficacy were diarrhea levels measured by maximum grade of diarrhea, incidence of diarrhea, and average diarrhea score. After completion of RT, the bowel function questionnaire was administered weekly for 4 weeks and at 12 and 24 months. Toxicity was measured by National Cancer Institute common toxicity criteria. Results: The median age of patients was 69 years (range, 34 to 86 years). The two treatment arms were balanced with respect to all baseline factors. There were no significant differences in toxicity by treatment. Quality-of-life scores and the mean number of problems reported on the bowel function questionnaire were virtually identical for both treatment groups. The incidence of grade 3 or higher diarrhea was 20% for the glutamine arm and 19% for the placebo arm (P = .99). The maximum number of stools per day was 5.1 for the glutamine arm and 5.2 for the placebo arm (P = .99). Conclusion: There is no evidence of a beneficial effect of glutamine during pelvic RT.

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