Non-small Cell Lung Cancer Clinical Trial
— NARLALOfficial 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.
NCT number | NCT00887783 |
Other study ID # | 09.01 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 1, 2009 |
Est. completion date | September 1, 2016 |
Verified date | April 2022 |
Source | Odense University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 117 |
Est. completion date | September 1, 2016 |
Est. primary completion date | September 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Oncology, Aalborg University Hospital | Aalborg | |
Denmark | Department of Oncology, Aarhus University Hospital | Aarhus | |
Denmark | Department of Oncology, Copenhagen University Hospital Herlev | Herlev | |
Denmark | Department of Oncology, Odense University Hospital | Odense | |
Denmark | Laboratory of Radiation Physics | Odense | |
Denmark | Department of Oncology, Vejle Hospital | Vejle |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital | Aalborg University Hospital, Aarhus University Hospital, Copenhagen University Hospital at Herlev, Rigshospitalet, Denmark, Vejle Hospital |
Denmark,
Hansen O, Knap MM, Khalil A, Nyhus CH, McCulloch T, Holm B, Brink C, Hoffmann L, Schytte T. A randomized phase II trial of concurrent chemoradiation with two doses of radiotherapy, 60Gy and 66Gy, concomitant with a fixed dose of oral vinorelbine in locall — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local Failure Free Survival | Local failure free survival 9 month after first RT treatment measured by CT/FDG-CT | 9 months | |
Secondary | Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy | 9 months | ||
Secondary | Local Tumour Control | Loco-regional control | 9 months | |
Secondary | Overall Survival | Overall survival, death of any cause | 72 months | |
Secondary | Late Toxicity | Late toxicity related to concurrent Vinorelbine and radiotherapy | 48 months | |
Secondary | Disease Free Survival | Disease free survival, death of any cause | 72 months |
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