Clinical trial NCT00887783: Navelbine And Radiotherapy in Locally Advanced Lung Cancer
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Induction chemotherapy
Non-small cell lung cancer
Randomized phase II study
Navelbine Oral (R)
3D-conformal radiotherapy
Chemo-radiotherapy
Local-regionally advanced non-small cell lung cancer
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Vejle Hospital
name: Rigshospitalet, Denmark
name: Aalborg University Hospital
name: Copenhagen University Hospital at Herlev
First posted: 2009-04-24
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study was 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 consisted 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 was included in the study after completing the induction chemotherapy. Randomization took place only if an acceptable dose plan could be obtained.

Primary endpoint: local recurrence free interval

Eligibility criteria: 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

Primary outcomes:
measure: Local Failure Free Survival
timeFrame: 9 months
Secondary outcomes:
measure: Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy
timeFrame: 9 months
measure: Local Tumour Control
timeFrame: 9 months
measure: Overall Survival
timeFrame: 72 months
measure: Late Toxicity
timeFrame: 48 months
measure: Disease Free Survival
timeFrame: 72 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Oncology, Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Department of Oncology, Aarhus University Hospital
city: Herlev
country: Denmark
facility: Department of Oncology, Copenhagen University Hospital Herlev
city: Odense
country: Denmark
facility: Department of Oncology, Odense University Hospital
city: Odense
country: Denmark
facility: Laboratory of Radiation Physics
city: Vejle
country: Denmark
facility: Department of Oncology, Vejle Hospital
Study officials:
affiliation: Odense University Hospital
name: Olfred Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 locally advanced NSCLC. Radiother Oncol. 2017 May;123(2):276-281. doi: 10.1016/j.radonc.2017.03.017. Epub 2017 Apr 11.