A multicentre,single arm,confirmatory trial to evaluate the effectiveness of induction CDDP plus TS-1 with concurrent radiotherapy(66Gy) followed by surgical resection in patients with superior sulcus tumor.
- Conditions
- Superior sulcus tumor
- Registration Number
- JPRN-UMIN000014386
- Lead Sponsor
- Advanced Clinical Trial chest surgery Group (ACTG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Not provided
(1) Distant metastasis (2) malignant pleural effusion, pericardial effusionintrathoracic seeding. (3) Uncontrollable systemic disease (hyper tension, diabetes mellitus etc.) (4) Case with the administration of the flucytosine. (5) Severe drug allergy (6) Infection requiring intravenous administration of anti-viral agents antibiotics, or antifungals (7) Hepatitis Bs antigen positive (8) History of severe heart disease , Current or previous (within the last 1 year) history of myocardial infarction (9) Traumatic fracture of unrecovery ,a high degree of wound (10) Severe diarrhea (11) Investigational new drug or the unapproved drug is administered (12) Interstitial pneumonia or pulmonary fibrosis detectable on chest CT (13) History of active double cancer (14) History of pregnancy or lactation or Women suspected of being pregnant.Men who wish to make a child. or no intention to contraception (15) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year overall survival
- Secondary Outcome Measures
Name Time Method 3-year and 5-year progression-free survival, 5-year overall survival,Completion rate of the protocol treatment,Complete resection rate,Radiological response rate,Down staging rate,Safety, Pathological response (Ef),Tumor markers (CEA/CYFRA),SUVmax on FDG-PET scan