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Selective Pulmonary Artery Perfusion with carboplatin for the treatment of NSCLC: a phase I trial

Selective Pulmonary Artery Perfusion with carboplatin for the treatment of NSCLC: a phase I trial - Selective Pulmonary Artery Perfusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32894
Enrollment
12
Registered
2008-11-25
Start date
2008-11-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer non-small cell lung cancer

Interventions

Insertion of a balloon catheter into the left or right pulmonary artery after venous puncture in the groin. After insertion, the drug is infused
depending on the group, a balloon will be inflated after infusion during 10, 20 or 30 minutes
after infusion and/or balloon inflation, the catheter will be removed immediately.

Sponsors

cardioth chir
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Stage c3a en c3b NSCLC

Exclusion criteria

Exclusion criteria: Other stages of NSCLC, age under 18 years old (however, NSCLC has never been described during childhood), patients who are mentally not able to chose whether to be involved in the study or not, pregnancy or lactation, severe comorbidity, uncontrollable infectious disease, Liver/kidney insufficiency; serum creatinine more than 130 µmol/l and urine creatinine clearance less than 60 ml/min, ALAT and ASAT more than 3 times normal

Design outcomes

Primary

MeasureTime frame
Primary endpoint: toxicity (CTC criteria)

Secondary

MeasureTime frame
Secondary endpoint: radiologic response, downstaging, radical resection

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)