Radiation Therapy Plus Chemotherapy in Treating Patients With Non-small Cell Lung Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01134861
• Date of registration: 28/05/2010
• Primary sponsor: Radiation Therapy Oncology Group
• Public title: Radiation Therapy Plus Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
• Scientific title: A THREE-ARM PHASE III STUDY OF CONCOMITANT VERSUS SEQUENTIAL CHEMOTHERAPY AND THORACIC RADIOTHERAPY FOR PATIENTS WITH LOCALLY ADVANCED INOPERABLE NON-SMALL CELL LUNG CANCER
• Date of first enrolment: January 2009
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01134861
• Study type: Interventional
• Study design: Primary Purpose: Treatment

Contacts

• Name: Walter J. Curran, MD
• Affiliation: Kimmel Cancer Center (KCC)

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS: Locoregionally advanced, inoperable, non-small cell lung cancer
with no evidence of distant metastases, i.e.: Stage II/IIIA medically inoperable disease
Stage IIIA/IIIB unresectable disease No pleural effusion Appearance after an invasive
thoracic procedure allowed No more than 5% weight loss within 3 months prior to diagnosis
Confirmed N2 disease should first be evaluated for protocol RTOG-9309

PATIENT CHARACTERISTICS: Age: At least 18 Performance status: Karnofsky 70%-100%
Hematopoietic: AGC at least 2,000 Platelets at least 100,000 Hemoglobin at least 8.0 g/dL
Hepatic: (unless abnormality caused by benign disease) Bilirubin no more than 1.5 times
normal AST no more than 1.5 times normal Renal: Creatinine no more than 1.5 mg/dL
Cardiovascular: No myocardial infarction within the past 6 months No angina No congestive
heart failure No uncontrolled arrhythmia Other: No synchronous or prior invasive
malignancy within 3 years except nonmelanomatous skin cancer No pregnant women Effective
contraception required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic or neck
radiotherapy Surgery: No prior complete or nearly complete tumor resection



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Cancer

Intervention(s)

Drug: cisplatin

Drug: etoposide

Drug: vinblastine

Radiation: low-LET electron therapy

Radiation: low-LET photon therapy

Secondary ID(s)

CDR0000063640

RTOG-9410

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)