Efficacy and safety of Adjuvant Pemetrexed plus cisplatin for post-operative adenocarcinoma
- Conditions
- Neoplasms
- Registration Number
- KCT0002816
- Lead Sponsor
- Chonnam National University Hospital Hwasun Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 106
Male or Female older than 19 years old
- Adenocarcinoma of Lung
- Stage IB~IIIA according to TNM classification (version 7)
- Completely resected lung cancer (RO resection)
* Definition of R0 resection
1) N1-2: R/O resection with lobectomy & mediastinal LN dissection(MLND)
2) N0: R/O resection with lobectomy with or without MLND
- First dose of Adjuvant chemotherapy should be within 4 to 8 weeks after surgery.
- Weight loss =10% within 3 months
- Adequate organ function
Absolute Neutrophil Count >1.500/mm³, Platelet>100,000/mm³,
WBC>3,000/ mm³,Hemoglobin>9g/dL
Bilirubin=1.5×ULN, AST/ALT<2.5×ULN
Creatinine clearance=30mL/min, Serum creatinine=1.5mg/dL
- Subjects who did not received cytotoxic chemotherapy or hormone therapy for lung cancer
- ECOG performance status 0-1
- Able to understand and willing to comply with scheduled visits, treatment plan and tests
- Women of child-bearing potential must have negative pregnancy test within 21 days of treatment and comply with highly effective contraception methods.
- Presence or history of malignant disease within the past 5 years.
- Subjects who received neoadjuvant chemotherapy before surgery.
- Subjects who require PORT, postoperative radiation therapy.
- Subjects with metastatic disease except regional lymph nodes.
- Severe infection requiring antibiotic treatment within 2 weeks.
- HIV positive cases
- Subjects with severe impairment of cardiopulmonary function
- Female subjects in breast feeding female or intent to child bearing during treatment
- History of autoimmune diseases or being treated with immune suppressive drugs
- Subjects with symptomatic Neuropathy > CTC grade 1
- Other severe disease or medical conditions (uncontrolled hypertension, diabetes mellitus, coronary artery disease, metabolic syndromes)
- Subjects with difficulties to comply with scheduled visits
- Subjects with severe bleeding diasthesis
- Subjects enrolled to other clinical trials within 3 months of screening
- Other uncontrolled medical conditions difined by the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease Free Survival Rate
- Secondary Outcome Measures
Name Time Method Overall Survival Rate;Adverse events, frequency and severity;Performance status score;4 cycles completion rate