Navelbine And Radiotherapy in Locally Advanced Lung Cancer

NCT ID: NCT00887783

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-01
• Study Completion Date: 2016-09-01

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

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Navelbine

Intervention Type: DRUG

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

66 Gy/33F

Intervention Type: RADIATION

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

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

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

Group Type: ACTIVE_COMPARATOR

Navelbine

Intervention Type: DRUG

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

60 Gy/30F

Intervention Type: RADIATION

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

Interventions

Navelbine

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

Intervention Type: DRUG

66 Gy/33F

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

Intervention Type: RADIATION

60 Gy/30F

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

Intervention Type: RADIATION

Other Intervention Names

Vinorelbine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Vejle Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Olfred Hansen

MD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olfred Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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

Laboratory of Radiation Physics

Odense, , Denmark

Department of Oncology, Vejle Hospital

Vejle, , Denmark

Countries

Denmark

References

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.

Reference Type: RESULT

PMID: 28410809 (View on PubMed)

Other Identifiers

09.01

Identifier Type: -

Identifier Source: org_study_id