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Navelbine And Radiotherapy in Locally Advanced Lung Cancer

NCT00887783 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2022-05-17

Study results available
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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.

Conditions

Interventions

DRUG

Navelbine

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

RADIATION

66 Gy/33F

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

RADIATION

60 Gy/30F

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

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Vejle Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Copenhagen University Hospital at Herlev

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Olfred Hansen, MD · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-01
Primary Completion
2016-09-01
Completion
2016-09-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00887783 on ClinicalTrials.gov