Changes in Left Ventricular Function after Radiation Therapy and Trastuzumab: Analysis of North Central Cancer Treatment Group Phase III Trial N9831

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]

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Faculty Opinions recommendation of Associations between cigarette smoking status and colon cancer prognosis among participants in North Central Cancer Treatment Group Phase III Trial N0147.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.717996345.793476875 ◽

2013 ◽

Author(s):

George Woody

Keyword(s):

Colon Cancer ◽

Treatment Group ◽

Cigarette Smoking ◽

Cancer Treatment ◽

Smoking Status ◽

Cancer Prognosis ◽

Phase Iii ◽

North Central ◽

Phase Iii Trial

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A phase III trial of 5-fluorouracil and leucovorin in the treatment of advanced colorectal cancer. A mayo clinic/north central cancer treatment group study

Cancer ◽

10.1002/1097-0142(19890315)63:6+<1026::aid-cncr2820631307>3.0.co;2-r ◽

1989 ◽

Vol 63 (S6) ◽

pp. 1026-1030 ◽

Cited By ~ 120

Author(s):

Michael J. O'Connell

Keyword(s):

Colorectal Cancer ◽

Treatment Group ◽

Cancer Treatment ◽

Mayo Clinic ◽

Advanced Colorectal Cancer ◽

Phase Iii ◽

North Central ◽

Phase Iii Trial

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Sucralfate in the Prevention of Treatment-Induced Diarrhea in Patients Receiving Pelvic Radiation Therapy: A North Central Cancer Treatment Group Phase III Double-Blind Placebo-Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.2000.18.6.1239 ◽

2000 ◽

Vol 18 (6) ◽

pp. 1239-1245 ◽

Cited By ~ 65

Author(s):

James A. Martenson ◽

John W. Bollinger ◽

Jeff A. Sloan ◽

Paul J. Novotny ◽

Rodolfo E. Urias ◽

...

Keyword(s):

Radiation Therapy ◽

Treatment Group ◽

Cancer Treatment ◽

Gastrointestinal Symptoms ◽

Phase Iii ◽

Double Blind ◽

North Central ◽

Pelvic Radiation ◽

Significant Difference ◽

Patient Reported

PURPOSE: Randomized studies have suggested that sucralfate is effective in mitigating diarrhea during pelvic radiation therapy (RT). This North Central Cancer Treatment Group study was undertaken to confirm the antidiarrheal effect of sucralfate. Several other measures of bowel function were also assessed.PATIENTS AND METHODS: Patients receiving pelvic RT to a minimum of 45 Gy at 1.7 to 2.1 Gy/d were eligible for the study. Patients were assigned randomly, in double-blind fashion, to receive sucralfate (1.5 g orally every 6 hours) or an identical looking placebo during pelvic RT.RESULTS: One hundred twenty-three patients were randomly assigned and found assessable. Overall, there was no significant difference in patient characteristics between those receiving sucralfate and those receiving placebo. Moderate or worse diarrhea was observed in 53% of patients receiving sucralfate versus 41% of those receiving placebo. Compared with patients receiving placebo, more sucralfate-treated patients reported fecal incontinence (16% v 34%, respectively; P = .04) and need for protective clothing (8% v 23%, respectively; P = .04). The incidence and severity of nausea were worse among those taking sucralfate (P = .03). Analysis of patient-reported symptoms 10 to 12 months after RT showed a nonsignificant trend toward more problems in patients taking sucralfate than in those taking placebo (average, 2.3 v 1.9 problems, respectively; P = .34).CONCLUSION: Sucralfate did not decrease pelvic RT-related bowel toxicity by any of the end points measured and seems to have aggravated some gastrointestinal symptoms.

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

Journal of Clinical Oncology ◽

10.1200/jco.2012.46.2457 ◽

2013 ◽

Vol 31 (16) ◽

pp. 2016-2023 ◽

Cited By ~ 36

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.

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