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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1071200033

Enrollment

Registered

2020-09-30

Start date

2020-10-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limited-disease small cell lung cancer

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 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 ==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

Exclusion criteria

Exclusion criteria: 1) 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

Design outcomes

Primary

Measure	Time frame
recommended dose	—

Secondary

Measure	Time frame
maximum tolerated dose, dose limiting toxicity, response rate, overall survival, progression free survival, adverse effects	—

Contacts

Public ContactKazumasa Akagi

Nagasaki University Graduate School of Biomedical Sciences

kaz.keepthefaith@gmail.com+81-95-819-7273

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026