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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

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ClinicalTrials.gov Identifier: NCT02397239
Recruitment Status : Unknown
Verified November 2017 by National Cheng-Kung University Hospital.
Recruitment status was:  Recruiting
First Posted : March 24, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

Brief 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


Condition or disease
Non-Small Cell Lung Cancer

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : March 2015
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Six cycles
Maintenance pemetrexed 500 mg/m2 every 3 weeks for six cycles
Until disease progression
Maintenance pemetrexed 500 mg/m2 every 3 weeks until disease progression



Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Cost-effectiveness: Cost/QA-PFS [ Time Frame: 2 years ]
    Quality-adjusted progression-free survival (QA-PFS)

  2. Overall survival [ Time Frame: 1 year ]
  3. Quality-of-life (QoL) Questionnaire [ Time Frame: 1 year ]
  4. Quality-adjusted progression-free survival (QA-PFS) [ Time Frame: 1 year ]
  5. Quality-adjusted life expectancy (QALE) [ Time Frame: 1 year ]
  6. Tumor response rate [ Time Frame: 1 year ]
  7. Number of Adverse events [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
Blood hemoglobin, white blood cell, absolute neutrophil count, platelet count, total bilirubin, aspartate aminotransferase, alanine aminotransferase, creatinine


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with metastatic non-squamous mon-small-cell lung cancer
Criteria

Inclusion Criteria:

  1. Males and females ≥ 20 years of age
  2. ECOG performance status of 0-1
  3. Histologically or cytologically verified non-squamous NSCLC
  4. Stage IV disease, as defined by American Joint Committee on Cancer 7th edition staging, prior to first-line or second-line chemotherapy with pemetrexed plus platinum
  5. At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  6. Completion of 4 cycles of first-line or second-line chemotherapy with pemetrexed plus platinum and documented radiographic evidence of a complete or partial tumor response or stable disease by RECIST 1.1
  7. Adequate organ function, including followings:

    Bone marrow:

    Absolute neutrophil count ≥ 1.5 x 103 /μL White blood cell ≥ 3.0 x 103 /μL Platelet count ≥ 75 x 103 /μL Hemoglobin ≥ 8.0 g/dL

    Hepatic:

    Total bilirubin ≤ 1.5 x upper normal limit (UNL) Aspartate aminotransferase (AST) ≤ 3.0 x UNL (≤ 5.0 x UNL if liver metastasis) Alanine aminotransferase (ALT) ≤ 3.0 x UNL (≤ 5.0 x UNL if liver metastasis)

    Renal:

    Estimated glomerular filtration rate ≥ 30 mL/min

  8. Estimated life expectancy of at least 6 months
  9. Ability to comply with study and follow-up procedures
  10. Signed informed consent document

Exclusion Criteria:

  1. Squamous cell and/or mixed small-cell, non-small-cell histology
  2. Prior participation in any investigational drug study within 4 weeks
  3. Prior malignancy other than NSCLC, except those remain disease-free for ≥ 3 years after curative treatment, non-melanoma skin cancer or in situ cervical cancer
  4. Serious concomitant systemic disorders, such as acute or recent myocardial infarction (< 6 months before enrollment), congestive heart failure with New York Heart Association functional class II~IV, frequent exacerbations of chronic obstructive pulmonary disease (≥ 2 hospitalizations per year), or recent cerebrovascular disease (< 6 months before enrollment)
  5. Active uncontrolled infections or HIV infection
  6. Current or planned pregnancy, or breast feeding in women
  7. Symptomatic central nervous system metastasis unless the patient has completed successful local therapy and has been off corticosteroids for ≥ 4 weeks
  8. Concurrent administration of any other antitumor therapy including chemotherapy, target therapy, immunotherapy, and hormone therapy
  9. Psychiatric disorders that would compromise the patient's compliance or decision

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): NCT02397239


Contacts
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Contact: Szu-Chun Yang, M.D. +886-6-2353535 ext 2595 szuchunyang@yahoo.com.tw

Locations
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Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Szu-Chun Yang, M.D.    +886 972402279    yangszuchun@gmail.com   
Sponsors and Collaborators
National Cheng-Kung University Hospital
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Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT02397239    
Other Study ID Numbers: A-BR-103-062
MOHW103-TD-B-111-06 ( Other Grant/Funding Number: The Ministry of Health and Welfare, Taiwan )
MOHW103-TDU-B-211-113002 ( Other Grant/Funding Number: The Ministry of Health and Welfare, Taiwan )
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms