Advanced or relapsed squamous cell carcinoma of the lung
Conditions
Interventions
TS-1 after induction therapy with carboplatin plus TS-1
Best supportive care after induction therapy with carboplatin plus TS-1
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Induction therapy 1) Cytologically or histologically documented squamous cell carcinoma of the lung. Non-small-cell lung cancer with a predominant squamous component or adenosquamous carcinoma with a predominant squamous component is also acceptable. 2) Clinical stage IIIB, IV or postoperative recurrence, and unsuitable for radiotherapy. 3) Patient must have received no prior chemotherapy. Adjuvant chemotherapy permitted providing cytotoxic chemotherapy was completed 6 months prior to recurrence of the disease. 4) The case can eat. 5) Have measurable lesion 6) Must be 20 or more years old at the time of consent. 7) Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0~1 8) Have adequate organ function within two week before study entry 9) Estimated life expectancy of at least 12 weeks 10) Have signed an informed consent document Maintenance therapy Meet eligibility criteria between day15 and day43 (day 1 is the date when patients receive last dose of induction therapy) 1) Documented evidence of NOT PD at CT scan conducted during cycle4 of induction therapy 2) Have ECOG PS 0~1 at the time of randomization 3) Have adequate organ function within 1 weeks before randomization
Exclusion criteria
Exclusion criteria: Induction therapy 1) SVC syndrome 2) Clinically significant drug allergy 3) Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment 4) Have received radiation therapy or surgery to lesions of lung 5) Patient received palliative radiotherapy except to the primary lesion in last 2 weeks. 6) With severe infection, bleeding, cardiac diseases. 7) With continues diarrhea 8) Ileus or sub-ileus 9) With interstitial pneumonia, sever COPD 10) Symptomatic brain metastasis 11) Presence of other active malignancy 12) Un-controlled DM 13) Uncontrolled psychiatric disease. 14) pregnancy or lactating patients 15) Positive serum HBs antigen 16) Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival from the date of randomization for maintenance therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, QOL and adverse events from the date of randomization for maintenance therapy, Progression free survival and overall survival from the date of enrollment | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group datacenter
Outcome results
None listed