Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung

• Status: Completed
• Trial end date: 2021-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chonnam National University Hospital
• Collaborators: Chungnam National University Hospital; Korea University Guro Hospital; Kosin University Gospel Hospital; Kyungpook National University; Kyungpook National University Hospital; Pusan National University Hospital; Severance Hospital
• Treatments: Cisplatin; Pemetrexed

Criteria

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