Navelbine And Radiotherapy in Locally Advanced Lung Cancer

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Navelbine
* Radiation: 66 Gy/33F
* Radiation: 60 Gy/30F


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B: 66Gy/33F+Navelbine oral 150 mg q3w<br>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 | Drug: Navelbine<br>* Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks<br>* Other names: Vinorelbine;Radiation: 66 Gy/33F<br>* irradiation to 66 Gy (2 Gy x 30, 5 F á weeks)<br>|
| Active Comparator: A: 60Gy/30F+Navelbine oral 150 mg q3w<br>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 | Drug: Navelbine<br>* Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks<br>* Other names: Vinorelbine;Radiation: 60 Gy/30F<br>* irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Failure Free Survival | Local failure free survival 9 month after first RT treatment measured by CT/FDG-CT | 9 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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