Research for optimal administration method of maintenance therapy with S-1 and CBDCA combination chemotherapy followed by S-1 in advanced lung squamous cell carcinoma

Research for optimal administration method of maintenance therapy with S-1 and CBDCA combination chemotherapy followed by S-1 in advanced lung squamous cell carcinoma - Research for optimal administration method of maintenance therapy with S-1 and CBDCA combination chemotherapy followed by S-1 in advanced lung squamous cell carcinoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011662

Enrollment

Registered

2013-09-05

Start date

2013-09-05

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

Advanced lung squamous cell carcinoma

Interventions

Administration method 1:first dose CBDCA :AUC5(day1)+ S-1:80mg/m2(day1-14) q3weeks Administration method 2:Platelet &lt

75,000/mm3 or grade 3 adverse event at Administration method 1 CBDCA :AUC5(day1)+ S-1:80mg/m2(day1-14) q4weeks Administration method 3:Platelet &lt

75,000/mm3 or grade 3 adverse event at administration method 2, or on and after 7th course S-1:80mg/m2(day1-14) q3weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with histlogically or cytologically confirmed lung squamous cell carcinoma 2)Patients with clinical stage of IIIB-IV or recurrence after operation 3) 20<=, <75 years old 4)ECOG Performance status 0-1 5) Expected survival more than 3 months 6)A measurable lesion according to the Response Evaluation Criteria in Solid Tumors 7) With ability of oral intake 8)No prior chemotherapy nor radiation therapy 9)Adequate bone marrow reserve and organ function 10)Written IC

Exclusion criteria

Exclusion criteria: 1)Patients with interstitial pneumonia or pulmonary fibrosis on Chest X-ray 2)Patients with pleural or pericardial effusion ,or ascites 3) Patients with active double cancer 4)Patients with significant complications a) Uncontrolled angina pectoris, myocardial infarction, heart failure within 3 months b)Uncontrolled diabetes or hypertension c)Current severe infection, or suspicious of severe infection d) Patients whose participation in the trial is judged to be inappropriate by the attending doctor. (e.g., ileus, bleeding tendency, diarrhea and varicella) 5)Patients with symptomatic brain metastasis 6)Patients with pregnancy or lactation 7) History of serious drug allergy 8) History of serious allergic reaction with CBDCA or other platinum-containing drug 9) History of serious allergic reaction with S-1 10) Being treated with other pyrimidine fluoride antineoplastic agents. 11) Being treated with flucytosine. 12) Any patients judged by the investigator to be unfit to participate in the study

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS)	—

Secondary

Measure	Time frame
Overall survival (OS), Response rate (RR) and Safety	—

Countries

Japan

Contacts

Public ContactYoshiki Ishii

Dokkyo Medical University Department of Pulmonary Medicine and Clinical Immunology

ishiiysk@dokkyomed.ac.jp0282-87-2151

Outcome results

None listed

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