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Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer


Phase 3
20 Years
N/A
Not Enrolling
Both
Radiotherapy Induced Nausea and Vomiting

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Trial Information

Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer


Inclusion Criteria:



- AJCC 1-3 staged gastrointestinal cancer patient

- patient undergoing radiotherapy as treatment

- age 20 yr and higher

- ECOG 0-2

Exclusion Criteria:

- age < 20

- ECOG 3-4

- patient experiencing nausea or vomiting prior to accrual

- patient under antiemetic medication

- patient under steroid medication (topical or inhalant steroid application are
exceptional)

- patient under opioid medication

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

complete response of RINV (no vomiting and no rescue medication)

Outcome Time Frame:

4 weeks after medication

Safety Issue:

No

Authority:

South Korea: Institutional Review Board

Study ID:

RMS vs ODS for CRINV

NCT ID:

NCT00971399

Start Date:

September 2009

Completion Date:

Related Keywords:

  • Radiotherapy Induced Nausea and Vomiting
  • Nausea
  • Vomiting
  • Gastrointestinal Neoplasms

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