Induction chemotherapy with Carboplatin and Navelbine Oral® followed by concomitant Navelbine Oral® and irradiation in local-regionally advanced non-small cell lung cancer. A randomized phase II study.

Phase 1

• Conditions: ocal-regionally advanced non-small cell lung cancer.; MedDRA version: 9.1Level: LLTClassification code 10061873Term: Non-small cell lung cancer

• Registration Number: EUCTR2008-008920-34-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-21
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Age =18 years
-Patients with histologically or cytologically documented diagnosis of locally advanced NSCLC stage IIB to IIIB without pleural effusion.
-Performance status 0-1 on the ECOG scale.
-Weight loss =10% during the last 6 months
-Adequate lung function measured as FEV1 =1.0.
- Neutrophile count =1.5 x 109/L and platelet count =100 x 109/L.
-Serum bilirubin =1.5 upper limit of normal (ULN).
- ALAT =2 x ULN
- Able to comply with study and follow-up procedures
- Patients with reproductive potential must use effective contraception.
-Written (signed) informed consent to participate in the study.

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
Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
-Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease).
-Any other active malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
-Prior chemotherapy for lung cancer, including neo- and adjuvant chemotherapy.
-Inability to take oral medication, or requirement of intravenous alimentation
-Active peptic ulcer disease.
-Nursing mothers.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified