NCT01536691

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
338

participants targeted

Target at P50-P75 for phase_3 cancer

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_3 cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

October 3, 2012

Status Verified

February 1, 2012

Enrollment Period

1.4 years

First QC Date

October 4, 2011

Last Update Submit

October 2, 2012

Conditions

CancerMalignancy

Keywords

ramosetronondansetronaprepitantchemotherapy induced nausea & vomiting

Outcome Measures

Primary Outcomes (1)

  • complete response (CR)

    CR means no vomiting \& no rescue medication

    acute phase (within 24 hrs after onset of chemotherapy)

Secondary Outcomes (1)

  • complete response

    during delayed phase and whole study period

Study Arms (2)

ramosetron, aprepitant, dexamethasone

EXPERIMENTAL

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

ondansetron, aprepitant, dexamethasone

ACTIVE COMPARATOR

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

Interventions

ramosetronDRUG

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

Also known as: Nasea - ramosetron, Emend - aprepitant
ramosetron, aprepitant, dexamethasone
ondansetronDRUG

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

Also known as: zofran - ondansetron, Emend - aprepitant
ondansetron, aprepitant, dexamethasone

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • ECOG performance status 0-2
  • Available oral administration of study drugs
  • 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

You may not qualify if:

  • 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)
  • Patients with GI obstruction, active gastric ulcer or other diseases that could provoke nausea and vomiting
  • Patients who have nausea and vomiting within 1 week before chemotherapy
  • 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
  • Patients with brain tumor, brain metastasis or seizure
  • Patients receiving chemotherapy within 12 months before enrollment
  • Patients who need radiation therapy during study period or receiving radiation therapy within 2 weeks before chemotherapy
  • Patients who have known allergy or severe side effect on study drugs
  • Pregnant or lactating women, or women who wish to become pregnant
  • Others whom the investigator judges inappropriate as subjects for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hyo Jung Kim

Anyang-si, Gyeonggi-do, 431070, South Korea

RECRUITING

MeSH Terms

Conditions

NeoplasmsVomiting

Interventions

ramosetronOndansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Sangwon Shin, M.D.

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyo Jung Kim, M.D. Ph.D.

CONTACT

82313803704hemonc@hallym.or.kr

Jinjoo Hong, R.N.

CONTACT

82232763517datacenter7@kcsg.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2011

First Posted

February 22, 2012

Study Start

June 1, 2011

Primary Completion

November 1, 2012

Study Completion

February 1, 2013

Last Updated

October 3, 2012

Record last verified: 2012-02

Locations

KR(1)