NIPH Clinical Trials Search

JRCT ID: jRCT1071200033

Registered date:30/09/2020

Phase I study of Amrubicin plus CISplatin and concurrent accelerated hyperfractionated thoracic radioTherapy for limited-disease small cell lung cancer

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedLimited-disease small cell lung cancer
Date of first enrollment02/10/2020
Target sample size9
Countries of recruitment
Study typeInterventional
Intervention(s)4 courses of chemotherapy below are administered every 4 weeks. course 1 AMR day1-3 25-20 mg/m2/day CDDP day1 60 mg/m2/day course 2-4 AMR day1-3 35 mg/m2/day CDDP day1 60 mg/m2/day Radiotherapy(1.5 Gy, twice daily, 5 days a week, total 45 Gy) is administered from day2 of course 1.


Primary Outcomerecommended dose
Secondary Outcomemaximum tolerated dose, dose limiting toxicity, response rate, overall survival, progression free survival, adverse effects

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
Include criteria1) Histologically or cytologically confirmed small cell lung cancer. Combined small cell lung cancer is acceptable. 2) Limited disease 3) Age between 20-75 when registered 4) Performance status (ECOG) 0 or 1 when registered 5) Regardless of measurable lesions 6) No prior chemotherapy 7) No active multiple cancer 8) The latest clinical laboratory test within 14 days prior to registration meets the following; 1. Neutrophil count >=1500 / mcL 2. Platelet count >=10X104 / mcL 3.Total-Bilirubin =<1.5 mg/ dL 4. Aspartate aminotransferase =<100 U/ L 5. Alanine aminotransferase =<100 U/ L 6. Serum creatine =<1.2 mg/dL 7. SpO2 >=92 % 8. Radiologists expect sufficient respiratory function to be preserved after the chemoradiotherapy. Calculating the actual value of V20(volume of normal lung irradiated over 20 Gy compared to all lung volume) or proportion of irradiation field for one-lung is not necessary before registration and the estimation by chest X ray or computed tomography is acceptable. Evaluation criteria whether desirable respiratory function is preserved after radiotherapy is V20 =<35 . 9) Written informed consent
Exclude criteria1) Lobectomy is acceptable 2) Symptoms by pericardial effusion 3) Urgent radiation therapy is necessary for superior vena cava syndrome. 4) Persistent angina, myocardial infarction within three months, persistent heart failure 5) Persistent diabetes 6) Persistent Hypertension 7) Active systemic infection calling for treatment 8) Pregnant, possibly pregnant, postpartum within 28 days, breastfeeding, men considering childbirth. 9) Body temperature over 38.0 degrees Celcius 10) Mental disorder or symptoms interfere with daily life and judged to be inappropriate to enroll. 11) Continuous intravenous or oral administration of steroids or immunosuppressants 12) HBs antigen positive or HCV antibody positive. 13) HIV antibody positive (not necessarily examined) 14) Computed tomography shows interstitial pneumonia, pulmonary fibrosis or emphysema. 15) Other in appropriate complications

Related Information


Public contact
Name Kazumasa Akagi
Address 1-7-1 Sakamoto, Nagasaki, Nagasaki Nagasaki Japan 852-8523
Telephone +81-95-819-7273
Affiliation Nagasaki University Graduate School of Biomedical Sciences
Scientific contact
Name Hirokazu Taniguchi
Address 1-7-1, Sakamoto, Nagasaki, Nagasaki Nagasaki Japan 852-8501
Telephone +81-95-819-7273
Affiliation Nagasaki University Hospital