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

JRCT ID: jRCT1071200033

Registered date:30/09/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Limited-disease small cell lung cancer
• Date of first enrollment: 02/10/2020
• Target sample size: 9
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: recommended dose
• Secondary Outcome: maximum 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
• Gender: Both

Include 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 =<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 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

Related Information

• Primary Sponsor: Taniguchi Hirokazu