A phase II study of chemoradiotherapy with use of involved-field conformal radiotherapy and accelerated hyperfractionation for Stage III non-small cell lung cancer
- Conditions
- Stage III non-small cell lung cancer
- Registration Number
- JPRN-UMIN000010428
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 44
Not provided
(1)Chest CT shows active interstitial pneumonia or pulmonary fibrosis or severe pulmonary emphysema. (2)The patient has SVC syndrome. (3)The patient has one or more nodal metastases as listed below; supraclavicular node, anterior scalene node, contralateral hilar node. These nodes are assumed as positive if they are FDG/PET positive and have more than 5mm diameter. Malignant pleural effusion, malignant pericardial effusion and malignant lymphangitis are also ineligible. (4)The patient has a history of previous thoracic radiotherapy. (5)The patient has active previous or concomitant malignancies. (6)The patient has uncontrolled diabetes mellitus. (7) The patients has active local or systemic infection, which should be treated. (8)The patient has a severe complication (ex.gastrointestinal bleeding, heart disease, glaucoma, HIV infection). (9) The patient has a history of allergy against agents containing polyoxyethilene oil or severe drug allergy. (10) The patient has psychiatric disorders that may comprise the patient s ability to comply with the study. (11) Positive serum HBs antigen or HCV antibody. (12) The patient is pregnant, may be pregnant, or is lacting. The patient, if is of child-bearing potential, does not practice contraception. (13) In the view of the investigator, the patient can and will comply with the requirement of the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Three-year survival ratio
- Secondary Outcome Measures
Name Time Method Annual year survival ratio, Median survival time, Local control rate, The ratio of the patients who completed the course, Adverse events