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

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ClinicalTrials.gov Identifier: NCT01536691
Recruitment Status : Unknown
Verified February 2012 by Hallym University Medical Center.
Recruitment status was:  Recruiting
First Posted : February 22, 2012
Last Update Posted : October 3, 2012
Sponsor:
Collaborators:
Korean Cancer Study Group
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Hallym University Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Cancer Malignancy Drug: ramosetron Drug: ondansetron Phase 3

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):

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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)
Study Start Date : June 2011
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : February 2013


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. complete response (CR) [ Time Frame: acute phase (within 24 hrs after onset of chemotherapy) ]
    CR means no vomiting & no rescue medication


Secondary Outcome Measures :
  1. complete response [ Time Frame: during delayed phase and whole study period ]
    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).



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT01536691     History of Changes
Other Study ID Numbers: ROAD
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Ondansetron
Aprepitant
Fosaprepitant
Ramosetron
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs