CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 117 enrolled
Drug / intervention
Navelbine +2 moredrug
Likely dose
Navelbine 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00887783
NCT00887783Phase 2Completed
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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.

Odense University Hospital·interventional·Posted Apr 24, 2009·Updated May 17, 2022

In Brief

A Phase 2 clinical trial evaluating Navelbine, 66 Gy/33F, and 1 other intervention for Non-small Cell Lung Cancer. Completed, enrolled 117 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesDenmark
CollaboratorsAarhus University Hospital, Vejle Hospital, Rigshospitalet, Denmark, Aalborg University Hospital, Copenhagen University Hospital at Herlev

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 24, 2009
Enrollment StartMay 1, 2009
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 17.2 years ago

Interventions

Navelbinedrug

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

66 Gy/33Fradiation

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

60 Gy/30Fradiation

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