Non-small Cell Lung CancerPhase 2NARLALNCT00887783
Navelbine And Radiotherapy in Locally Advanced Lung Cancer
A Phase 2 study testing Navelbine, 66 Gy/33F and 60 Gy/30F in people with Non-small Cell Lung Cancer, run by Odense University Hospital at 6 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Navelbine, 66 Gy/33F and 60 Gy/30F
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 6 sitesDenmark
- Study dates
- 1 May 2009to 1 Sep 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Department of Oncology, Aalborg University Hospital
Aalborg, 9100
Department of Oncology, Aarhus University Hospital
Aarhus, 8000
Department of Oncology, Copenhagen University Hospital Herlev
Herlev, 2730
Department of Oncology, Odense University Hospital
Odense, 5000
Laboratory of Radiation Physics
Odense, 5000
Department of Oncology, Vejle Hospital
Vejle, 7100
About this study
Official title: 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.
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.
Read the 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
- Being tested
- Navelbine, 66 Gy/33F, 60 Gy/30F
- Keywords
- Induction chemotherapy, Non-small cell lung cancer, Randomized phase II study, Navelbine Oral (R), 3D-conformal radiotherapy, Chemo-radiotherapy, Local-regionally advanced non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavelbineDrug
Also called Vinorelbine
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)
| Study group | Role | What they receive |
|---|---|---|
| B: 66Gy/33F+Navelbine oral 150 mg q3w | Experimental | 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 Receives: Drug: Navelbine; Radiation: 66 Gy/33F |
| A: 60Gy/30F+Navelbine oral 150 mg q3w | Active comparator | 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 Receives: Drug: Navelbine; Radiation: 60 Gy/30F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Failure Free Survival
Local failure free survival 9 month after first RT treatment measured by CT/FDG-CT
Measured: 9 months
Secondary outcomes (5)
Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy
Measured: 9 months
Local Tumour Control
Loco-regional control
Measured: 9 months
Overall Survival
Overall survival, death of any cause
Measured: 72 months
Late Toxicity
Late toxicity related to concurrent Vinorelbine and radiotherapy
Measured: 48 months
Disease Free Survival
Disease free survival, death of any cause
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study start1 May 2009
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Vejle Hospital, Copenhagen University Hospital, Rigshospitalet, Aalborg University Hospital, Copenhagen University Hospital at Herlev
- Responsible party
- Principal investigator, Olfred Hansen, Odense University Hospital
- Investigators
- Olfred Hansen, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887783
- Sponsor's protocol ID
- 09.01
- Acronym
- NARLAL
- Status last verified
- Apr 2022
- First submitted
- 23 Apr 2009
- Last updated
- 17 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Further studies on toxicity profiles and PET may be performed
Publications
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.
PubMed 28410809
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00887783
- Acronym / sponsor ID
- NARLAL / 09.01
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Induction chemotherapy, Non-small cell lung cancer, Randomized phase II study, Navelbine Oral (R), 3D-conformal radiotherapy, Chemo-radiotherapy, Local-regionally advanced non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Vejle Hospital, Copenhagen University Hospital, Rigshospitalet, Aalborg University Hospital, Copenhagen University Hospital at Herlev
- Study start
- 1 May 2009 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 24 Apr 2009 (estimated)
- Results
- Posted 8 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B: 66Gy/33F+Navelbine oral 150 mg q3w | Experimental | Drug: Navelbine, Radiation: 66 Gy/33FNavelbine 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 |
| A: 60Gy/30F+Navelbine oral 150 mg q3w | Active comparator | Drug: Navelbine, Radiation: 60 Gy/30FNavelbine 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NavelbineAlso: VinorelbineNavelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks | Drug | A: 60Gy/30F+Navelbine oral 150 mg q3w, B: 66Gy/33F+Navelbine oral 150 mg q3w |
| 66 Gy/33Firradiation to 66 Gy (2 Gy x 30, 5 F á weeks) | Radiation | B: 66Gy/33F+Navelbine oral 150 mg q3w |
| 60 Gy/30Firradiation to 60 Gy (2 Gy x 30, 5 F á weeks) | Radiation | A: 60Gy/30F+Navelbine oral 150 mg q3w |
Primary outcome
Local Failure Free Survival
Time frame: 9 months
Local failure free survival 9 month after first RT treatment measured by CT/FDG-CT
5 secondary outcomes
Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy
Time frame: 9 months
Local Tumour Control
Time frame: 9 months
Overall Survival
Time frame: 72 months
Late Toxicity
Time frame: 48 months
Disease Free Survival
Time frame: 72 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28410809Hansen 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.
- Individual participant dataSharing planned: Undecided. Further studies on toxicity profiles and PET may be performed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olfred Hansen, MD principal investigator
Odense University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Navelbine, 66 Gy/33F and 60 Gy/30F in people with Non-small Cell Lung Cancer, run by Odense University Hospital at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Failure Free Survival (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00887783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022; AzTrials last refreshed its copy on 26 Oct 2026.