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Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone

Information source: Hallym University Medical Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer; Malignancy

Intervention: ramosetron (Drug); ondansetron (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hallym University Medical Center

Official(s) and/or principal investigator(s):
Sangwon Shin, M.D., Principal Investigator, Affiliation: Korea University Anam Hospital

Overall contact:
Hyo Jung Kim, M.D. Ph.D., Phone: 82313803704, Email: hemonc@hallym.or.kr

Summary

The purpose of this study is to assess the efficacy and safety of Ramosetron, Aprepitant and Dexamethasone therapy versus Ondansetron, Aprepitant and Dexamethasone therapy for preventing of nausea and vomiting in highly emetogenic chemotherapy (ROAD study):

Prospective multicenter, randomized, single blinded, phase III study.

Clinical Details

Official title: To Assess the Efficacy and Safety of Ramosetron, Aprepitant and Dexamethasone Therapy vs Ondansetron, Aprepitant and Dexamethasone Therapy for Preventing of Nausea and Vomiting in Highly Emetogenic Chemotherapy (ROAD Study)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Primary outcome: complete response (CR)

Secondary outcome: complete response

Detailed description: To assess the efficacy and safety of Ramosetron, Aprepitant and Dexamethasone therapy versus Ondansetron, Aprepitant and Dexamethasone therapy for preventing of nausea and vomiting in highly emetogenic chemotherapy (ROAD study):

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Patients diagnosed as malignancy who will be treated with highly emetogenic chemotherapeutic agents (NCCN guideline v1. 0 2011 anti-emesis), over 20 years and both sex

2. ECOG performance status 0-2

3. Available oral administration of study drugs

4. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

1. Severe Hypertension, severe Heart disease, kidney disease (serum creatinine > 3 mg/dl), liver disease (AST, ALT > 3 times of upper normal range, ALP > 2 times of upper normal range)

2. Patients with GI obstruction, active gastric ulcer or other diseases that could provoke nausea and vomiting

3. Patients who have nausea and vomiting within 1 week before chemotherapy

4. Patients who should take steroid, antiemetics, pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir or nelfinavir for the treatment of other diseases

5. Patients with brain tumor, brain metastasis or seizure

6. Patients receiving chemotherapy within 12 months before enrollment

7. Patients who need radiation therapy during study period or receiving radiation therapy within 2 weeks before chemotherapy

8. Patients who have known allergy or severe side effect on study drugs

9. Pregnant or lactating women, or women who wish to become pregnant

10. Others whom the investigator judges inappropriate as subjects for this study

Locations and Contacts

Hyo Jung Kim, M.D. Ph.D., Phone: 82313803704, Email: hemonc@hallym.or.kr

Hyo Jung Kim, Anyang, Gyeonggi-do 431070, Korea, Republic of; Recruiting
Hyo Jung Kim, M.D., Ph.D., Phone: 82313803704, Email: hemonc@hallym.or.kr
Hyo Jung Kim, M.D., Ph.D., Principal Investigator
Additional Information

Starting date: June 2011
Last updated: October 2, 2012

Page last updated: February 07, 2013

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