Adenocarcinoma, Lung Neoplasm
Conditions
Keywords
adenocarcinoma, lung, adjuvant chemotherapy, pemetrexed, cisplatin, surgery
Brief summary
Two-Year Disease Free Survival Rate of Stage IB\ IIIA adenocarcinoma after Adjuvant Chemotherapy with Pemetrexed and Cisplatin will be assessed. A total of 106 patients will be recruited for 12 months, and followed for two years, thus the duration of study will be 36 months.
Detailed description
Primary endpoint : 2 year disease free survival Secondary endpoints: Overall survival, Frequency and severity of adverse events
Interventions
DRUGPemebit
500mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles
DRUGCisplatin
75mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles
Sponsors
Kosin University Gospel Hospital
Korea University Guro Hospital
Severance Hospital
Chungnam National University Hospital
Kyungpook National University Hospital
Pusan National University Hospital
Chonnam National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adenocarcinoma of Lung * Postoperative pathologic stage IB\ IIIA * Complete surgical resection (R0 resection) N1-2: R0 resection with lobectomy and mediastinal lymph nodes dissection (MLND) N0: R0 resection with lobectomy with or without MLND * Adjuvant treatment should start between 4 to 6 weeks after surgery * ECOG performance status 0-1 * Weight loss during last 3 months should be less than 10%. * Normal hematologic, hepatic and renal function Neutrophil count \> 1500 /microliter, Platelet \> 100,000/microliter, Hemoglobin \> 9 g/dL Bilirubin \<=1.5 x upper limit normal, transaminase \< 2.5 x upper limit normal Serum Creatinine \<=1.5 mg/dL * Women in child bearing age should consent using contraceptive measures, and must have negative pregnancy test.
Exclusion criteria
* Other malignant neoplastic disease within 5 years. * Neoadjuvant chemotherapy before surgery of lung cancer * Patients who will be treated with postoperative radiation. * Stage IIIB or IV lung cancer * Severe infection, or cardiorespiratory, hematologic illness * HIV positive cases * Pregnancy or lactating women * Autoimmune diseases or those who receiving immune suppressive treatment * Symptomatic neuropathy \> CTCAE grade 1 * Those who consented other clinical trials within 3 months * Other significant medical conditions contraindicated to clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival rate | 2 year | Disease free survival time is measured from the date of enrollment to date of tumor recurrence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 4 year | Overall survival time is measured from the date of enrollment to date of death from any cause. Participants who are alive when the data lock or is lost to follow-up will have their overall survival time censored on the last date the participant is known to be alive. |
| Adverse events | 4 months | adverse events using common terminology criteria for adverse events 4.0 |
Countries
South Korea
Outcome results
None listed