Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung
- Registration Number
- NCT02498860
- Lead Sponsor
- Chonnam National University Hospital
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pemebit plus Cisplatin Pemebit Pemetrexed (Pemebit 500 mg/m2) plus cisplatin (75 mg/m2) every 3 weeks up to 4 cycles Pemebit plus Cisplatin Cisplatin Pemetrexed (Pemebit 500 mg/m2) plus cisplatin (75 mg/m2) every 3 weeks up to 4 cycles
- Primary Outcome Measures
Name Time Method Disease free survival rate 2 year Disease free survival time is measured from the date of enrollment to date of tumor recurrence.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (7)
Korea university Guro hospital
🇰🇷Seoul, Korea, Republic of
Severance hospital
🇰🇷Seoul, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Kyungpook National University Medical Center
🇰🇷Daegu, Kyungpook, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Jeonnam, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Pusan, Korea, Republic of