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

Phase 2

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: pemetrexed; Drug: carboplatin; Radiation: thoracic radiation

• Registration Number: NCT00886678
• Lead Sponsor: Zhejiang Cancer Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Status Verified: 2010-03
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2011-02-23
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	thoracic radiation	patients receiving pemetrexed, carboplatin and radiation therapy.
1	pemetrexed	patients receiving pemetrexed, carboplatin and radiation therapy.
1	carboplatin	patients receiving pemetrexed, carboplatin and radiation therapy.

Primary Outcome Measures

Name	Time	Method
tumor response rate	Tumor assessments after completion of chemoradiotherapy and every 2 months

Secondary Outcome Measures

Name	Time	Method
the safety profile	every cycle
site of first failure in patients who develop progressive disease	baseline to measured progressive disease
overall survival	baseline to date of death from any cause
time to progressive disease	baseline to measured progressive disease

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China