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Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone (ROAD)

This study is currently recruiting participants.
Verified February 2012 by Hallym University Medical Center
Sponsor:
Collaborators:
Korean Cancer Study Group
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT01536691
First received: October 4, 2011
Last updated: October 2, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cancer
Malignancy
 Drug: ramosetron
Drug: ondansetron
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:
  • complete response (CR) [ Time Frame: acute phase (within 24 hrs after onset of chemotherapy) ] [ Designated as safety issue: No ]
    CR means no vomiting & no rescue medication


Secondary Outcome Measures:
  • complete response [ Time Frame: during delayed phase and whole study period ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 338
Study Start Date: June 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ramosetron, aprepitant, dexamethasone
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
 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
Other Names:
  • Nasea - ramosetron
  • Emend - aprepitant
Active Comparator: ondansetron, aprepitant, dexamethasone
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
 Drug: 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
Other Names:
  • zofran - ondansetron
  • Emend - aprepitant

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536691

Contacts
Contact: Hyo Jung Kim, M.D. Ph.D. 82313803704 hemonc@hallym.or.kr
Contact: Jinjoo Hong, R.N. 82232763517 datacenter7@kcsg.org

Locations
Korea, Republic of
Hyo Jung Kim Recruiting
Anyang, Gyeonggi-do, Korea, Republic of, 431070
Contact: Hyo Jung Kim, M.D., Ph.D.     82313803704     hemonc@hallym.or.kr    
Principal Investigator: Hyo Jung Kim, M.D., Ph.D.            
Sponsors and Collaborators
Hallym University Medical Center
Korean Cancer Study Group
Astellas Pharma Korea, Inc.
Investigators
Principal Investigator: Sangwon Shin, M.D. Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT01536691     History of Changes
Other Study ID Numbers: ROAD
Study First Received: October 4, 2011
Last Updated: October 2, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Hallym University Medical Center:
ramosetron
ondansetron
aprepitant
chemotherapy induced nausea & vomiting

Additional relevant MeSH terms:
Neoplasms
Dexamethasone acetate
Dexamethasone
Ondansetron
Ramosetron
Aprepitant
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 16, 2013