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Pemetrexed Maintenance in Patients With Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy

NCT03193788 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2017-06-21

No results posted yet for this study

Summary

This study aims to verify superiority of pemetrexed maintenance to observation for patient without disease progression after 1 st line cisplatin-based chemotherapy.

Conditions

Interventions

DRUG

pemetrexed

Pemetrexed 500 mg/m2mixed in normal saline 100 mL as a 10 minute IV infusion on day 1 of each 21 day cycle

DRUG

Folic Acid

folic acid 1000 μg daily orally from 7 days prior to treatment initiation until the end of treatment

DRUG

Vitamin B12 Injection

vitamin B12 1000 μg IM 7 days prior to treatment initiation and the end of treatment

DRUG

Dexamethasone

Dexamethasone 4 mg twice orally for 3 days beginning the day before treatment until the end of treatment to minimize cutaneous reactions

Sponsors & Collaborators

  • Korean Cancer Study Group

    collaborator OTHER

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Jae-Lyun Lee, MD, PhD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-12-31
Completion
2020-06-30

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03193788 on ClinicalTrials.gov