Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments pemetrexed, carboplatin, thoracic radiation
Phase phase 2
Sponsor Zhejiang Cancer Hospital
Start date July 2008
End date July 2010
Trial size 63 participants
Trial identifier NCT00886678, ZhejiangCH01

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
patients receiving pemetrexed, carboplatin and radiation therapy.
pemetrexed
500 mg/m2, IV, q 21 days x 2 cycles
carboplatin
AUC=5,IV,q 21 days x 2 cycles
thoracic radiation
66 Gy over 33 fractions

Primary Outcomes

Measure
tumor response rate
time frame: Tumor assessments after completion of chemoradiotherapy and every 2 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title A Phase II Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer
Principal investigator Ma Sheng lin, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2011.
Information provided to ClinicalTrials.gov by Zhejiang Cancer Hospital.