Non-Small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, pemetrexed, radiation
Brief summary
Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy 66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500 mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).
Interventions
DRUGpemetrexed
500 mg/m2, IV, q 21 days x 2 cycles
DRUGcarboplatin
AUC=5,IV,q 21 days x 2 cycles
RADIATIONthoracic radiation
66 Gy over 33 fractions
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histologically proven non-small cell lung cancer (non-squamous cell carcinoma) * Presence of measurable disease by RECIST * Inoperable stage IIIA or IIIB * ECOG performance status 0-1 * No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy * Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.
Exclusion criteria
* Carcinoid tumor, small cell carcinoma of lung * Patients with any distant metastasis * History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment) * Pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women * Women and men of childbearing potential who have no willing of employing adequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tumor response rate | Tumor assessments after completion of chemoradiotherapy and every 2 months |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | baseline to date of death from any cause |
| time to progressive disease | baseline to measured progressive disease |
| the safety profile | every cycle |
| site of first failure in patients who develop progressive disease | baseline to measured progressive disease |
Countries
China
Outcome results
None listed