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Comparison of Cost-effectiveness of Continuation Maintenance Therapy With Six Cycles of Pemetrexed Versus Pemetrexed Until Disease Progression for Metastatic Non-squamous Non-small-cell Lung Cancer

NCT02397239 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2017-11-06

No results posted yet for this study

Summary

Protocol title:

Comparison of cost-effectiveness of continuation maintenance therapy with six cycles of pemetrexed versus pemetrexed until disease progression for metastatic non-squamous non-small-cell lung cancer (NSCLC)

Study design:

An open-labelled, randomized, phase 2 trial

Indication:

Patients with stage IV non-squamous NSCLC, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and have received first-line or second-line chemotherapy with pemetrexed plus platinum for 4 cycles

Treatment:

Maintenance pemetrexed 500 mg/m2 every 3 weeks for six cycles versus until disease progression

Objectives:

Primary endpoint:

1\. Progression-free survival in the intention-to-treat population

Secondary endpoints:

1. Cost-effectiveness
2. Overall survival
3. Quality-of-life (QoL)
4. Quality-adjusted progression-free survival (QA-PFS)
5. Quality-adjusted life expectancy (QALE)
6. Tumor response rate
7. Adverse events

Planned sample size:

36 patients in each arm; total 72 patients

Total number of sites:

1 site

Duration of patient enrollment:

3 years

Conditions

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    lead OTHER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-12-31

Countries

  • Taiwan

Study Locations

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Entities

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 NCT02397239 on ClinicalTrials.gov