Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments navelbine, irradiation-66 gy, irradiation-60 gy
Phase phase 2
Sponsor Odense University Hospital
Collaborator Aarhus University Hospital
Start date May 2009
End date August 2012
Trial size 114 participants
Trial identifier NCT00887783, 09.01

Summary

This study is an open label randomized multi-centre phase II trial in patients with inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general criteria for curatively intended irradiation. The treatment plan consists of two courses of inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day 1 of the last induction chemotherapy has been given. The patients will be included in the study after completing the induction chemotherapy. Randomization will take place only if an acceptable dose plan can be obtained.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)
navelbine Vinorelbine
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
irradiation-66 gy
irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)
(Active Comparator)
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)
navelbine Vinorelbine
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks
irradiation-60 gy
irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)

Primary Outcomes

Measure
Local failure free survival at 9 months after start of radiotherapy
time frame: May 2012

Secondary Outcomes

Measure
Toxicity
time frame: May 2012
Local tumour control
time frame: May 2012
Overall response rate (CR + PR)
time frame: May 2012
Local tumour control at 9 months evaluated by PET-CT
time frame: May 2012
Overall survival
time frame: May 2012
Disease free survival
time frame: May 2012
Late toxicity
time frame: May 2012

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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 Exclusion Criteria: - 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

Additional Information

Official title Induction Chemotherapy With Carboplatin and Navelbine Oral(R) Followed by Concomitant Navelbine Oral(R) and Irradiation in Local-regionally Advanced Non-small Cell Lung Cancer. A Randomized Phase II Study.
Principal investigator Olfred Hansen, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Odense University Hospital.