Navelbine And Radiotherapy in Locally Advanced Lung Cancer (NARLAL)

Odense University Hospital

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Radiation: 66 Gy/33F; Drug: Navelbine; Radiation: 60 Gy/30F

Study type: Interventional

Funder types: Other

Identifiers

NCT00887783

09.01

Details and patient eligibility

About

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.

Full 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

Enrollment: 117 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

B: 66Gy/33F+Navelbine oral 150 mg q3w

Experimental group

Description:

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

Treatment:

Radiation: 66 Gy/33F

Drug: Navelbine

A: 60Gy/30F+Navelbine oral 150 mg q3w

Active Comparator group

Description:

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

Treatment:

Drug: Navelbine

Radiation: 60 Gy/30F