Trials / Completed
CompletedNCT00887783
Navelbine And Radiotherapy in Locally Advanced Lung Cancer
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.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 117 (actual)
- Sponsor
- Odense University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2016-09-01
- Completion
- 2016-09-01
- First posted
- 2009-04-24
- Last updated
- 2022-05-17
- Results posted
- 2021-01-08
Locations
6 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT00887783. Inclusion in this directory is not an endorsement.