Navelbine And Radiotherapy in Locally Advanced Lung Cancer

Phase 2

Completed

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

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
B: 66Gy/33F+Navelbine oral 150 mg q3w	66 Gy/33F	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). Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
A: 60Gy/30F+Navelbine oral 150 mg q3w	60 Gy/30F	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) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
B: 66Gy/33F+Navelbine oral 150 mg q3w	Navelbine	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). Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
A: 60Gy/30F+Navelbine oral 150 mg q3w	Navelbine	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) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization

Primary Outcome Measures

Name	Time	Method
Local Failure Free Survival	9 months	Local failure free survival 9 month after first RT treatment measured by CT/FDG-CT

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy	9 months
Local Tumour Control	9 months	Loco-regional control
Overall Survival	72 months	Overall survival, death of any cause
Late Toxicity	48 months	Late toxicity related to concurrent Vinorelbine and radiotherapy
Disease Free Survival	72 months	Disease free survival, death of any cause

Locations (6): Department of Oncology, Aalborg University Hospital
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Aalborg, Denmark
Department of Oncology, Copenhagen University Hospital Herlev
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Herlev, Denmark
Department of Oncology, Odense University Hospital
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Odense, Denmark
Department of Oncology, Vejle Hospital
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Vejle, Denmark
Department of Oncology, Aarhus University Hospital
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Aarhus, Denmark
Laboratory of Radiation Physics
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Odense, Denmark