Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT00359567
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 20 or more at the time when they give consent.
* Diagnosed as malignant disease.
* Be naive to chemotherapy or have been treated with single administration of anti-tumor drugs which are classified as low emetogenicity in the first edition of the 2006 NCCN Clinical Practice Guidelines.
* Cisplatin ≥50 mg/m2 Doxorubicin + cyclophosphamide: AC Epirubicin + cyclophosphamide: EC
* WBC ≥ 3000 /mm3 AST \< 100 IU/L ALT \< 100 IU/L Creatinine clearance ≥ 60 mL/min
* Performance Status : 0 - 2
Exclusion Criteria:
* Severe (requiring hospitalization) and uncontrollable complications.
* Metastases to the brain which are symptomatic.
* Seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity.
* Symptomatic and invasive procedure indicated ascites or pleural effusion.
* Have either gastric outlet stenosis or intestinal obstruction.
* Have ongoing emesis or CTCAE grade 2 or greater nausea.
* QTc \> 470 msec in the 12-lead ECG within eight days before registration.
* Known anaphylactic to ingredients of the study drug, namely palonosetron or granisetron hydrochloride injection, or other 5-HT3 receptor antagonists.
* Known anaphylactic to ingredients of dexamethasone.
* Pregnant women, breast-feeding women, or any male or female who are not willing to practice adequate contraception during the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT00359567
Study Brief:
Protocol Section:
NCT00359567