Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone

Cancer Clinical Trial

— ROAD  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01536691
• Other study ID #: ROAD
• Status: Recruiting
• Phase: Phase 3
• First received: October 4, 2011
• Last updated: October 2, 2012
• Start date: June 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2012
• Source: Hallym University Medical Center
• Contact: Hyo Jung Kim, M.D. Ph.D.
• Phone: 82313803704
• Email: hemonc[@]hallym.or.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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):

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 338
• Est. completion date: February 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Malignancy

Intervention

Drug:
• ramosetron
ramosetron 0.3 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4
• ondansetron
ondansetron 16 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4

Locations

Country	Name	City	State
Korea, Republic of	Hyo Jung Kim	Anyang	Gyeonggi-do

Sponsors (3)

Lead Sponsor	Collaborator
Hallym University Medical Center	Astellas Pharma Korea, Inc., Korean Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete response (CR)	CR means no vomiting & no rescue medication	acute phase (within 24 hrs after onset of chemotherapy)	No
Secondary	complete response	Delayed phase means 'from day 2 to day 5' after onset of chemotherapty whole study period means 'from day 1 to day 5' after onset of chemotherapty (acute phase + delayed phase).	during delayed phase and whole study period	No