Overview

A Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0801)

Status:
Unknown status
Trial end date:
2010-07-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhejiang Cancer Hospital
Treatments:
Carboplatin
Pemetrexed
Criteria
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