Superior sulcus tumor
Conditions
Interventions
Induction concurrent chemoradiotherapy (CDDP+TS-1+RT66Gy) The surgical resection is performed after 3 cycles of chemotherapy with CDDP,TS-1 and RT45Gy(2Gy/fra/day,33fractions).
Sponsors
Advanced Clinical Trial chest surgery Group (ACTG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Histologically or cytologically proven non-small cell lung cancer,diagnosed using specimen material obtained from primary tumor or metastastatic lymph node. (2)Chest MRI or thoracic CT,direct invasion of the primary lesion to the organ of one of the following is suspected. a)Invasion to the first rib or more superior chest wall b)Subclavian vein or subclavian artery (3)cN0,cN1 (4)Patients with evaluable lesions or measurable disease. (5)Age>=20,=<75y (6)ECOG PS 0-1 (7)Expected FEV 1.0 > 800ml after lung resection,SpO2(Room air)>95% (8)Adequate organ function (9)Written informed consen
Exclusion criteria
Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKazuya Takamochi
Juntendo University Thoracic Surgery
Outcome results
None listed