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

Zhejiang Cancer Hospital63 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer

Interventions

pemetrexedDRUG

500 mg/m2, IV, q 21 days x 2 cycles

carboplatinDRUG

AUC=5,IV,q 21 days x 2 cycles

thoracic radiationRADIATION

66 Gy over 33 fractions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

tumor response rate

Time frame: Tumor assessments after completion of chemoradiotherapy and every 2 months

Secondary Outcomes

overall survival

Time frame: baseline to date of death from any cause

time to progressive disease

Time frame: baseline to measured progressive disease

the safety profile

Time frame: every cycle

site of first failure in patients who develop progressive disease

Time frame: baseline to measured progressive disease

Data from ClinicalTrials.gov

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