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
- Conditions
- Patient with locally advanced stage III non-small cell lung cancer.
- Registration Number
- EUCTR2005-003867-21-SE
- Lead Sponsor
- Sahlgrenska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
·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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Clinical benefit at 24 months (CR, PR or SD);Secondary Objective: Overall survival<br>Overall response rate<br>ToxicityQuality of life, <br>measured by EORTC QLQ 30 + LC 14<br>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.
- Secondary Outcome Measures
Name Time Method