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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)


Phase 3
20 Years
N/A
Open (Enrolling)
Both
Cancer, Malignancy

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Trial Information

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)


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):


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

complete response (CR)

Outcome Description:

CR means no vomiting & no rescue medication

Outcome Time Frame:

acute phase (within 24 hrs after onset of chemotherapy)

Safety Issue:

No

Principal Investigator

Sangwon Shin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Korea University Anam Hospital

Authority:

South Korea: Institutional Review Board

Study ID:

ROAD

NCT ID:

NCT01536691

Start Date:

June 2011

Completion Date:

February 2013

Related Keywords:

  • Cancer
  • Malignancy
  • ramosetron
  • ondansetron
  • aprepitant
  • chemotherapy induced nausea & vomiting
  • Neoplasms

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