MedPath

OGIK1902

Phase 2
Conditions
non-small cell lung cancer
Registration Number
JPRN-jRCTs071200019
Lead Sponsor
Harada Taishi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
45
Inclusion Criteria

1)Patients with histologically or cytologically confirmed non-small cell lung cancer.
2)No prior history of chemotherapy, thoracic radiotherapy or surgical resection
3)Unresectable stage 3disease.
4)V20 is under 35%.
5)There is measurable region.
6)Age>=75
7)Eastern Cooperative Oncology Group performance status=<1
8)Leucocyte>=4000/mm3, Neutrocyte>=2000/mm3, platelets>=100000/mm3, hemoglobin>=9.0g/dl, AST and ALT=<100, bilirubin=<1.5mg/dl and serum creatinine=<1.5mg/dl. PaO2>=65torr or SpO2>=92%
9)Written informed consent.

Exclusion Criteria

1)Involvement of contralateral hilar lymph nodes.
2)Interstitial pneumonia or pulmonary fibrosis detected with chest X-ray.
3)SVC syndrome.
4)Obstructive pneumonia or active severe infection.
5)Other active invasive malignancies
6)Severe complications such as gastrointestinal bleeding, significant heart failure or uncontrolled diabetes and so on.
7)History of severe hypersensitivity.
8)Regular use of corticosteroids.
9)Mental illness
10)Pregnant woman and lactating woman
11)Active hepatitis B
12)A case considered by an investigator inadequate for the trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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