Navelbine And Radiotherapy in Locally Advanced Lung Cancer

Odense University Hospital117 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

117

Conditions

Non-small Cell Lung Cancer

Interventions

NavelbineDRUG

Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks

66 Gy/33FRADIATION

irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)

60 Gy/30FRADIATION

irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (6)

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

Outcomes

Primary Outcomes

Local Failure Free Survival

Local failure free survival 9 month after first RT treatment measured by CT/FDG-CT

Time frame: 9 months

Secondary Outcomes

Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy

Time frame: 9 months

Local Tumour Control

Loco-regional control

Time frame: 9 months

Overall Survival

Overall survival, death of any cause

Time frame: 72 months

Late Toxicity

Late toxicity related to concurrent Vinorelbine and radiotherapy

Time frame: 48 months

Disease Free Survival

Disease free survival, death of any cause

Time frame: 72 months

Data from ClinicalTrials.gov

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