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Phase I study for the safty of the postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis

Phase I study for the safty of the postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis - Phase I study of postoperative urinastatin in patients with resectable lung cancer accompanied with interstitial pneumonitis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002410
Enrollment
9
Registered
2009-08-31
Start date
2009-09-01
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

interstitial pneumonitis lung cancer

Interventions

After the operation, intravenous infusion of designed amount of urinastatin is administered 9 times in every 8 hours.

Sponsors

Keio University School of Medicine, division of General Thoracic Surgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed lung cancer 2) cStage IA-IIIB, resectable 3) lung resection is planned 4) the case diagnosed as lung cancer with interstitial pneumonitis by one clinical radiologist in our hospital. The standard of diagnose is below. 1.coin lesion just under the pleura 2.honeycomb lung 3.tractional bronchitis, bronchioles ectasia 4.ground grass opacity 5.consolidation 5)performance status of 0 to 1 6)Adequate hematologic, hepatic, renal, and cardiac function diagnosed within 2 weeks before the registration. *WBC >=3,000/mm3 - <=12,000/mm3 *Absolute neutrophil count 1,500/mm3 - 5000/mm3 *Platelet count >=75,000/mm3 *Hemoglobin >=8.0g/dL *AST and ALT 2.5 times upper limit of normal *Total bilirubin <1.5mg/dL *Creatinine 1.5 times upper limit of normal *ECG normal *SpO2 90% (room air) 7) general anesthesia is permitted 8) Written informed consent

Exclusion criteria

Exclusion criteria: a)asbestosis b)Patients with interstitial pneumonitis caused by connective tissue disease c)chronic hypersensitivity pneumonitis d)sarcoidosis e)Patients who have the history of allergic reactions against urinastatin f)Patients who are pregnant or have possibility of pregnancy

Design outcomes

Primary

MeasureTime frame
Until 1POM, we are going to judge clinically whether adverse outcomes happen, which is thought to be side-effects caused by postoperative ulinastatin therapy.

Countries

Japan

Outcome results

None listed

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