The NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 is the new standard for oncology clinical trials

Colevas, A. D.; Setser, Ann

doi:10.1200/jco.2004.22.90140.6098

Cited by 48 publications

(25 citation statements)

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“…Adverse events were defined as per versions two or three of the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) criteria (Colevas et al, 2004). All data were extracted independently by two investigators (Luo and Han), and any discrepancy between the reviewers was resolved by consensus.…”

Section: Data Extraction and Outcomesmentioning

confidence: 99%

Meta-analysis of Six Randomized Control Trials of Chemotherapy Plus Anti-HER Monoclonal Antibody for Advanced Gastric and Gastroesophageal Cancer

Luo

Han²,

Jiang³

2014

Asian Pacific Journal of Cancer Prevention

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Section: Data Extraction and Outcomesmentioning

confidence: 99%

Meta-analysis of Six Randomized Control Trials of Chemotherapy Plus Anti-HER Monoclonal Antibody for Advanced Gastric and Gastroesophageal Cancer

Luo

Han²,

Jiang³

2014

Asian Pacific Journal of Cancer Prevention

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“…During treatment, patients were followed up weekly, for toxicities (short term toxicity, within 90 days and long term toxicity, > 90 days) using National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 [18] and disease related symptoms.…”

Section: Follow Upmentioning

confidence: 99%

Palliative Hypofractionated Radiotherapy in South Egyptian Patients with Stage III and IV Non-Small Cell Lung Cancer

Attia¹

2015

JCPCR

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Background: In patients with advanced non-small cell lung cancer the priority should be given to controlling symptoms of the disease and thoracic radiotherapy remains an important treatment modality for these patients. The use of shorter radiotherapy schedules has an economic and logistic advantage for radiotherapy departments, as well as a high degree of patient convenience. However there is still no consensus on which fractionation scheme should be used.The aim of the study is to evaluate the effect of hypofractionated regimen (36Gy/12 fractions versus 17Gy/2 weekly fractions regimen) on symptoms relief, assessment of treatment related toxicity and its impact on overall survival (OS) in patients with locally advanced stage III and stage IV non-small cell lung cancer (NSCLC). Patients and methods:Patients were randomly assigned into two treatment groups: 1, receive 36 Gy per 12 fractions and group 2, receive 17 Gy per two fractions. Assessments by clinician for improvement of symptoms and toxicity were done weekly during radiotherapy, one month, 3 months and every 3 months thereafter. Symptomatic response was assessed by comparing the initial score for each symptom with the best score during follow-up period. A total symptom score (TSS) was produced for each patient, by adding the scores of each individual symptom. Results:The total symptom scores before radiotherapy was significantly higher to that after radiotherapy (Wilcoxon signed-rank test Z=-6.434, P=.0001). The degree and duration of symptom relief were equivalent in the treatment groups. There were no reported cases of grade 3 or 4 esophagitis or pulmonary toxicity. Grade 2 acute esophagitis was greater among patients received 36 Gy/ 12 fractions compared to those received 17 Gy/ 2 fractions (26.3% vs 14%, P = .177) but did not reach statistical significance. Two patients (3.5%) experienced grade 2 acute pneumonitis. No significant difference in survival among treatment groups was found (one year OS for group 1, was 22.3% and for group 2, was 20.4%, P = .434).Conclusion: 17Gy/2 weekly fractions regimen, provide good symptomatic relief with comparable survival to 36Gy/12 fractions regimen and should be used for patients requesting a shorter treatment course especially in which palliative chemotherapy is planned.

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“…17 The efficacy of the ramosetron has been supported by several clinical trials comparing antiemetic efficacy of ramosetron with that of granisetron in 76 patients receiving cisplatin chemotherapy. 16 Results are strongly in favour of ramosetron.…”

Section: Discussionmentioning

confidence: 75%

“…The adverse events were evaluated as per the Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE). 16 If any adverse event occurred, it was evaluated by the investigator and recorded in case record form stating the onset, severity, duration, likely cause, action taken reference to the study drugs and outcome.…”

Section: Adverse Event Monitoringmentioning

confidence: 99%

Comparative study of effects of ramosetron and ondansetron on global satisfaction of patients on cisplatin chemotherapy in head and neck cancers

Srivastava¹,

Ahmed²,

Sayedda³

2017

Int J Basic Clin Pharmacol

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Background: To compare level of satisfaction of the patients receiving ramosetron and ondansetron in prevention of acute and delayed nausea and vomiting associated with cisplatin chemotherapy.Methods: 60 patients were recruited in the study. Patients were randomly allocated to ramosetron (R) and ondansetron group (O). Patients were screened between day 1 and day 7. Study visits included clinic visits on day 8, day 9 and day 14. Patient diaries were used to record patients’ global satisfaction which was based on severity of nausea and vomiting using visual analogue scale (VAS), recorded daily until day 12 starting from day 8. On 14th day the patient diary cards were collected back.Results: VAS score was significantly lower in R group (46.2±4.95) as compared to O group (63.7±5.06) (p<0.01) in acute phase of nausea and vomiting indicating level of satisfaction higher in R group. Similarly, in delayed and overall phase R group (49.57±14.63 and 48.9±12.91 respectively) experienced lower range of scoring on VAS scale as compared to O group (63.0±8.49 and 63.10±7.38 respectively). The difference was statistically significant (p<0.01).Conclusions: Level of overall satisfaction of the patients in R group was significantly higher as compared to O group in patients receiving the two drugs for prevention of nausea and vomiting caused by cisplatin chemotherapy in head and neck cancer patients.

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The NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 is the new standard for oncology clinical trials

Cited by 48 publications

References 0 publications

Meta-analysis of Six Randomized Control Trials of Chemotherapy Plus Anti-HER Monoclonal Antibody for Advanced Gastric and Gastroesophageal Cancer

Meta-analysis of Six Randomized Control Trials of Chemotherapy Plus Anti-HER Monoclonal Antibody for Advanced Gastric and Gastroesophageal Cancer

Palliative Hypofractionated Radiotherapy in South Egyptian Patients with Stage III and IV Non-Small Cell Lung Cancer

Comparative study of effects of ramosetron and ondansetron on global satisfaction of patients on cisplatin chemotherapy in head and neck cancers

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