Assessment of efficacy and safety of continouation maintenance therapy with gemcitabine after cisplatin-gemcitabine induction chemotherapy in advanced squamous cell lung cancer (KTORG1302)

Phase 2

Recruiting

• Conditions: squamous cell lung cancer

• Registration Number: JPRN-UMIN000010721
• Lead Sponsor: Kyoto Thoracic Oncology Research Group (KTORG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with histologically proven non-squamous cell lung cancer 2) Recognized ILD or pulmonary fibrosis on X-rays 3) Pleural effusion, peritoneal fluid and pericardial fluid that need treatment 4) Superior vena cava syndrome 5) Symptomatic brain metastasis 6) Active concomitant malignancy 7) Prior therapy with gemcitabine 8) Diabetes and hypertension that cannot be controlled 9) Liver cirrhosis 10) Symptomatic or asymptomatic but treated heart disease 11) Severe infectious disease 12) Pregnant women, possibly pregnant women, wishing to become pregnant 13) Serious drug hypersensitivity or a history of drug allergy 14) Refusal of supportive care such as blood transfusion 15) Bleeding tendency 16) Other conditions not suitable for this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival

Secondary Outcome Measures

Name	Time	Method
Overall survival Safety response rate