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Induction chemotherapy with docetaxel and cisplatin followed by radiotherapy concomitant with cetuximab for locally advanced stage III non-small cell lung cancer- amulticentre, open label non-randomised phase II trial - Satellit

Induction chemotherapy with docetaxel and cisplatin followed by radiotherapy concomitant with cetuximab for locally advanced stage III non-small cell lung cancer- amulticentre, open label non-randomised phase II trial - Satellit

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-003867-21-SE
Enrollment
75
Registered
2005-11-24
Start date
2005-12-21
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Patient with locally advanced stage III non-small cell lung cancer.

Interventions

Product Name: Erbitux Product Code: EMD271786 Pharmaceutical Form: Solution for infusion Product Name: Taxotere Pharmaceutical Form: Solution for infusion Product Name: Cisplatin Pharmaceutical Form

Sponsors

Sahlgrenska University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ·Histological or cytological diagnosis of a NSCLC Stage IIIA/IIIB Non- resectable or medically inoperable patients. Received no prior chemotherapy or radiation therapy for NSCLC PS WHO 0 - 1. FEV1 ³ 1L or ³ 40% of expected volume. Adequate bone marrow reserve: WBCC ³ 3.0 ´ 109/L, Platelets ³100 ´ 109/L, Haemoglobin ³100 ml/l .· Age ³18 years, no upper age limit. 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: Evidence of active infection at the discretion of the investigator.· Inadequate liver function: Bilirubin >1,5 x UNL, ALAT or ASAT >3,0 UNL· Inadequate kidney function: creatinine >1,5 x UNL or GFR < 50 ml/min.·Pleural effusion with positive cytology· Serious concomitant systemic disorder incompatible with the study.· Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) unless treated, in remission and off active treatment for greater than 5 years.

Design outcomes

Primary

MeasureTime frame
Main Objective: Clinical benefit at 24 months (CR, PR or SD);Secondary Objective: Overall survival Overall response rate ToxicityQuality of life, measured by EORTC QLQ 30 + LC 14 Relapse pattern;Primary end point(s): Clinical benefit at 24 months (CR, PR or SD) when induction chemotherapy with docetaxel and cisplatin followed by radiotherapy concomitant with weekly cetuximab is given.—

Countries

Sweden

Outcome results

None listed

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