Lung cancer Lung cancer
Conditions
Interventions
[S-1 and cisplatin with concurrent thoracic radiotherapy]
Radiotherapy: 60 Gy / 30 fr, 5 times a week
Chemotherapy: 1 course 28 days x 2 coursesCDDP (60 mg / m2, Day 1) IV infusion
S-1 (80-120 mg, Day
Sponsors
Tanzawa Shigeru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary registration 1. Informed consent is given to the patients themselves before the start of the study, and written consent has been obtained 2. Men and women aged 20 and over at the start of treatment 3. Non-small cell lung cancer diagnosed with histopathology or cytology (not including small cell carcinoma), unresectable locally advanced stage lung cancer (Stage IIIA / IIIB / IIIC) (IASLC staging manual in Thoracic Oncology, According to Version 8th) 4. Patients with measurable lesions based on RECIST ver. 1.1 5. No previous history of chemotherapy (including molecular targeted drugs, immune checkpoint inhibitors) and chest radiation therapy, including treatment for other carcinomas. 6. 12 weeks or more expected to survive 7. ECOG Performance Status 0-1 8. Maintaining organ function and bone marrow function as follows (latest examination value within 14 days of registration) Neutrophil count > 1500 / mm3 Platelet count > 100,000 / mm3 Hemoglobin > 9.0 g / dL Serum creatinine 50 mL / min (by the Cockcroft-Gault formula) Bilirubin = 92% or PaO2 >= 70 Torr (room air) 9. Possibility of radical concurrent chemoradiotherapy (V20 1500 / mm3 Platelet count> 100,000 / mm3 Hemoglobin >9.0 g / dL Serum creatinine 50 mL / min (by the Cockcroft-Gault formula) Bilirubin 92% or PaO 2> 70 Torr (room air)
Exclusion criteria
Exclusion criteria: Primary registration 1. Patients with interstitial pneumonia or pulmonary fibrosis evident on chest CT 2. Patients with a history of serious allergies or hypersensitivity to therapeutic agents 3. Patients who are medically contraindicated for therapeutic agents 4. Patients who have a history of allogeneic organ transplantation 5. Patients who have used immunotherapy or investigational drug within 4 weeks of starting treatment (monoclonal antibody within 6 weeks) 6. Patients with active or previous autoimmune disease , or patients with active inflammatory disease (inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), colonic diverticulitis, SLE, sarcoidosis, polyangiitis granulomatosis, Graves' disease, rheumatoid arthritis, hypophysitis, grape (With a history of less than 2 years), or patients with a coexistence / history of primary immunodeficiency. However, registration is permitted if Patients with vitiligo or alopecia Stable hypothyroidism during hormone replacement therapy (eg Hashimoto's disease) All chronic skin diseases that do not require systemic therapy Patients who have not been active in the past 5 years will be allowed to register,Limited to later registration Celiac disease patients controlled only by diet therapy 7. Patients with active or infectious diseases being treated 8. Patients with a mixture of small cell lung cancer and non-small cell lung cancer 9. Patients who use a therapeutic agent that has an immunosuppressive effect within 28 days from the start of study treatment (excluding systemic steroid treatment with nasal or inhaled steroids, or equivalent to 10 mg/ day or less in terms of prednisolone) 10. Patients who have had surgery within 4 weeks prior to enrollment 11. Patients with SVC syndrome that has difficulty in high-volume infusion, symptomatic heart failure, arrhythmia requiring hospitalization,uncontrolled hypertension, unstable angina, active peptic ulcer, mental disease patients who have difficulty in maintaining treatment compliance 12. Patients with hepatitis B merger (positive for HBs antigen), HCV antibody positive patients (registration is allowed if the polymerase chain reaction of HCV RNA is negative) 13. Patients with a history of malignancy within 5 years of treatment (excluding basal cell carcinoma of the skin and CIS in the cervix) 14. Patients who have used attenuated live vaccination within 30 days of study registration 15. Patients who have no intention of contraception during the treatment period and at least 90 days after the end of treatment 16. Patients who are willing to donate blood during the treatment period and at least 90 days after the end of treatment 17. Pregnant or breast feeding patients 18. Patients judged to be ineligible by the investigator Secondary registration 1. Patients who had grade 2 or more radiation pneumonitis by the time of secondary registration 2. Patients with uncontrolled disease or active or treating infections 3. Patients who use a therapeutic agent that has an immunosuppressive effect within 28 days from the start of study treatment (excluding nasal or inhaled steroids, or systemic steroid treatment equivalent to 10 mg / day or less in terms of prednisolone conversion) However, chemoradiation The administration of steroids as antiemetics in treatment is acceptable. 4. Patients with unrecovered Grade 2 or higher toxicity in induction chemotherapy chemoradiotherapy, excluding test values defined in alopecia, vitiligo, and selection cr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year progression free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) Response rate (ORR) 18-month overall survival Safety and adverse event profile (based on CTCAE, ver. 5.0) Chemotherapy completion rate, radiation therapy completion rate, chemoradiotherapy completion rate Durvalumab maintenance therapy transfer rate PFS from the start of maintenance therapy | — |
Contacts
Public ContactShigeru Tanzawa
Teikyo University School of Medicine
Outcome results
None listed