Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.

Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer. - Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009308

Enrollment

Registered

2013-01-01

Start date

2012-12-01

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

Squamous cell carcinoma of the lung

Interventions

Induction chemotherapy with Carboplatin and alternate-day administrations of TS-1 for all registered patients. Maintenance chemotherapy with alternate-day administrations of TS-1 for non-PD patien

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed squamous cell carcinoma of the lung 2.Stage IIIB/IV 3.Age >=20 4.PS(Eastern Cooperative Oncology Group:ECOG):0-2 5.Measurable lesion 6.Capable of oral intake 7.Adequate organ functions neutrophils >=1,500/mm3 platelets >=100,000/mm3 hemoglobin >=9.0g/dL total bilirubin <=2.0mg/dL AST(GOT)/ALT(GPT) <=100IU/L PaO2 >= 60torr or SpO2 >=90% creatinine clearance >=30mL/min 8.Estimated life expectancy of at least 3 months 9.With written informed consent

Exclusion criteria

Exclusion criteria: 1.Contraindication of TS-1, CBDCA 2)Patients received adjuvant chemotherapy 3.Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy 4.Active infection 5.HBs antigen positive 6.Severe complications, such as ileus, heart failure and renal failure 7.Continuous diarrhea 8.Massive pleural effusion and ascites 9.Active concomitant malignancy 10.Patients under treatment with flucytosine, phenytoin or warfarin potassium 11.Patients under treatment with steroids 12.Inadequate physical condition, as diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
Disease control rate (CR+PR+SD)	—

Secondary

Measure	Time frame
1.Overall survival 2.Progression-free survival from induction chemotherapy 3.Progression-free survival from maintenance chemotherapy 4.Percrntages of patients who received maintenance chemotherapy 5.Response rate 6.Toxicities	—

Countries

Japan

Contacts

Public ContactHiroki Nagai

Kyoto University Hospital Respiratory Medicine

hwithe@kuhp.kyoto-u.ac.jp075-751-3830

Outcome results

None listed

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