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Multicenter fase III undersøgelse af effekten af præoperativ (neoadjuverende) kemoterapi inden operation med efterfølgende adjuverende kemoterapi ved operabel NSCLC stadie IB, IIA; IIB, og IIIA/T3.

Multicenter fase III undersøgelse af effekten af præoperativ (neoadjuverende) kemoterapi inden operation med efterfølgende adjuverende kemoterapi ved operabel NSCLC stadie IB, IIA; IIB, og IIIA/T3.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-003503-39-DK
Enrollment
1228
Registered
2006-08-08
Start date
2006-09-08
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

operable NSCLC. Pts are randomized to receive or not receive two courses of neoadjuvant chemotherapy before surgery

Interventions

Trade Name: taxotere Product Name: taxotere Product Code: L01CD02 Pharmaceutical Form: Intravenous infusion Trade Name: carboplatin Product Name: carboplatin Product Code: L01XA02 Pharmaceutical Form

Sponsors

Jens Benn Sorensen, Dept. oncology, Finsen Centre/National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: NSCLC resectable disease normal organ function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: abnormal liver-, renal-, or bone marrow function inability to understand the protocol information inability to cooperate with the protocoll treatment

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluate the impact of two courses of neoadjuvant chemotherapy on the survival rate in resectable non-small cell lung cancer;Secondary Objective: time to progression and response rate ;Primary end point(s): survival

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026