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
NCT ID: NCT02397239
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
72 participants
OBSERVATIONAL
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Criteria for evaluation:
QoL:
QoL will be measured using the EuroQol 5-dimensional questionnaire (EQ-5D), World Health Organization Quality-of-Life, brief version (WHOQOL-BREF), European Organization for Research and Treatment of Cancer (EORTC) questionnaires.
Efficacy:
Tumor response rate will be determined by RECIST 1.1. Data of progression-free survival and overall survival will be collected for all subjects.
QA-PFS and QALE:
Investigators will adjust the progression-free survival by the utility values of QoL measured from the EQ-5D to obtain the QA-PFS. In addition, investigators will extrapolate the survival function to lifetime based on the survival ratios between patients and age- and sex-matched referents simulated from the life tables of Taiwan. After adjusting the lifetime survival by the utility values of QoL, the QALE will also be estimated using quality-adjusted life-year (QALY) as the unit.
Cost-effectiveness:
The monthly healthcare expenditures, which included National Health Insurance-reimbursed and out-of-pocket direct medical costs, will be obtained from the reimbursement database of National Cheng Kung University Hospital. These values were multiplied by the corresponding survival probabilities to calculate the lifetime costs or costs during the progression-free period. Hence, costs/life-year or costs/QALY can be obtained for comparison of cost-effectiveness.
Adverse events:
Safety parameters include laboratory adverse events (e.g., anemia, leukopenia, neutropenia, thrombocytopenia, creatinine, AST, ALT) and non-laboratory adverse events (e.g., fatigue, nausea, vomiting, mucositis/stomatitis, anorexia, diarrhea, constipation, infection, febrile neutropenia, pain, sensory neuropathy, rash, edema, watery eye). Common Terminology Criteria for Adverse Events (CTCAE) v4.0 will be used to grade toxicities.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Six cycles
Maintenance pemetrexed 500 mg/m2 every 3 weeks for six cycles
No interventions assigned to this group
Until disease progression
Maintenance pemetrexed 500 mg/m2 every 3 weeks until disease progression
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cheng-Kung University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Szu-Chun Yang, M.D.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MOHW103-TD-B-111-06
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MOHW103-TDU-B-211-113002
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
A-BR-103-062
Identifier Type: -
Identifier Source: org_study_id