NSCLCNCT02354274
Novel Approach to Radiotherapy in Locally Advanced Lung Cancer Concomitant Navelbine®
A study testing Escalated: Inhomogeneous dose plan and Standard: Homogeneous dose plan in people with NSCLC, run by Olfred Hansen at 7 sites in Denmark.
Trial summary
To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on an inhomogeneous dose distribution controlled by FDG-PET positive areas compared to a standard homogeneous dose spread Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Escalated: Inhomogeneous dose plan and Standard: Homogeneous dose plan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 7 sitesDenmark
- Study dates
- Jan 2015to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically proven locally advanced NSCLC stage IIB to IIIB
- Performance status 0-1
- Able to comply with treatment and follow study and follow-up procedures
- Women must have negative pregnancy test
- Signed, informed consent
- Plan for radiotherapy with conventional 66 Gy/ 33 F, which meets all dosing limits two normal tissue must be available
Who cannot join
- Any unstable systemic disorder (including infection , unstable angina, congestive heart failure , severe liver , kidney or metabolic disease)
- Need for nasal oxygen
- Former thoracic radiotherapy, unless there is no significant overlap with previous fields
- Any other active malignant disease
- Unable to take oral medications or needing intravenous nutrition
- Ulcer
- Nursing women
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Denmark7 sites, 7 recruiting
- Not yet recruiting
Aalborg University Hospital
Aalborg, 9100
Svetlana Kunwald, MD
Svetlana Kunwald, MD
- Recruiting
Aarhus University Hospital
Aarhus, 8000
Marianne M. Knap, MD
Marianne M. Knap, MD
- Not yet recruiting
Rigshospitalet
Copenhagen, 2100
Gitte F. Persson, MD
- Recruiting
Herlev University Hospital
Herlev, 2730
Jon L. Andersen, MD
Jon L. Andersen, MD
- Not yet recruiting
Department of Oncology, Naestved Hospital
Næstved
Kim Wederwang, MD, kwd@regionsjaelland.dk
Kim Wedervang, MD
- Recruiting
Department of Oncology, Odense University Hospital
Odense, 5000
Olfred Hansen, MD, +45 6541 1867, olfred.hansen@rsyd.dk
Olfred Hansen, MD
- Recruiting
Department of Oncology, Vejle Hospital
Vejle, 7100
Christa Haugaard, MD
Christa Haugaard, MD
About this study
Official title: Novel Approach to Radiotherapy in Locally Advanced Lung Cancer - Heterogeneous FDG-guided Dose Escalation With Concomitant Navelbine®
To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on an inhomogeneous dose distribution controlled by FDG-PET positive areas compared to a standard homogeneous dose spread
Read the detailed description
To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on an inhomogeneous dose distribution controlled by FDG-PET-positive areas compared to a standard homogeneous dose spread.
- Conditions
- NSCLC
- Being tested
- Escalated: Inhomogeneous dose plan, Standard: Homogeneous dose plan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escalated: Inhomogeneous dose planRadiation
Standard: Homogeneous dose planRadiation
| Study group | Role | What they receive |
|---|---|---|
| Standard: Homogeneous dose plan | Active comparator | Treatment will be given over 33 treatments. The dose is 66 Gy. Receives: Radiation: Standard: Homogeneous dose plan |
| Escalation: Inhomogeneous dose plan | Experimental | Radiation dose is increased to tumor and lymph nodes based on an inhomogeneous dose distribution determined by the most active ( FDG-PET criteria ) area of the node compared to a standard uniform dose distribution.
Treatment will be given over 33 treatments. The dose is as high as possible taking the tolerance of the normal tissue into consideration Receives: Radiation: Escalated: Inhomogeneous dose plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional control (Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen)
Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen ) every 3 months combined with PET/CT every 9 months or if occurrence is clinically suspected. Suspicion of tumor relapse local, regional or distant should be verified by biopsy. Date of detected recurrence is the date of the imaging modality suspecting relapse. The patient will be censured at death without local relapse.
Measured: 5-7 years
Secondary outcomes (3)
Toxicity (graded after CTCAE 4.0 assessed by physician)
Acute and late toxicity graded after CTCAE 4.0 assessed by physician at scheduled follow-up visits
Measured: 10 years
Survival
Time from randomization to exact date of death of any cause.
Measured: 15 years
Progression free survival
Time from randomization to date of progression, death, or occurence of metastatic disease
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olfred Hansen
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Aarhus University Hospital, Copenhagen University Hospital, Rigshospitalet, Vejle Hospital, Naestved Hospital, Aalborg University Hospital, Herlev Hospital
- Responsible party
- Sponsor-investigator, Olfred Hansen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354274
- Sponsor's protocol ID
- NARLAL 2
- Status last verified
- Apr 2022
- First submitted
- 19 Jan 2015
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Schytte T, Knap MM, Kristiansen C, Appelt AL, Khalil A, Peucelle C, Lutz CM, Moller DS, Sande EPS, Sundby F, Persson G, Schmidt H, Land LH, Rogg L, Pohl M, Lund MD, Nielsen M, Levin N, Hansen O, Thing RS, Borissova S, Halvorsen T, Nielsen TB, Hansen TS, Haakensen VD, Ottosson W, Brink C, Hoffmann L. Toxicity Within 6 Months of Heterogeneous Fluorodeoxyglucose-Guided Radiotherapy Dose Escalation for Locally Advanced Non-Small Cell Lung Cancer in the Scandinavian Randomized Phase III NARLAL2 Trial. J Clin Oncol. 2025 Jun 10;43(17):1972-1983. doi: 10.1200/JCO-24-01386. Epub 2025 Apr 18.
PubMed 40249893
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approach to Radiotherapy in Locally Advanced Lung Cancer - Heterogeneous FDG-guided Dose Escalation With Concomitant Navelbine®
- ClinicalTrials.gov ID
- NCT02354274
- Acronym / sponsor ID
- NARLAL 2
- Conditions
- NSCLC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Olfred HansenUniversity, hospital or other
- Collaborators
- Odense University Hospital, Aarhus University Hospital, Copenhagen University Hospital, Rigshospitalet, Vejle Hospital, Naestved Hospital, Aalborg University Hospital, Herlev Hospital
- Study start
- Jan 2015 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on an inhomogeneous dose distribution controlled by FDG-PET positive areas compared to a standard homogeneous dose spread
Detailed description
To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on an inhomogeneous dose distribution controlled by FDG-PET-positive areas compared to a standard homogeneous dose spread.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard: Homogeneous dose plan | Active comparator | Radiation: Standard: Homogeneous dose planTreatment will be given over 33 treatments. The dose is 66 Gy. |
| Escalation: Inhomogeneous dose plan | Experimental | Radiation: Escalated: Inhomogeneous dose planRadiation dose is increased to tumor and lymph nodes based on an inhomogeneous dose distribution determined by the most active ( FDG-PET criteria ) area of the node compared to a standard uniform dose distribution. Treatment will be given over 33 treatments. The dose is as high as possible taking the tolerance of the normal tissue into consideration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically or cytologically proven locally advanced NSCLC stage IIB to IIIB
- Performance status 0-1
- Able to comply with treatment and follow study and follow-up procedures
- Women must have negative pregnancy test
- Signed, informed consent
Key exclusion criteria (7 listed)
- Any unstable systemic disorder (including infection , unstable angina, congestive heart failure , severe liver , kidney or metabolic disease)
- Need for nasal oxygen
- Former thoracic radiotherapy, unless there is no significant overlap with previous fields
- Any other active malignant disease
- Unable to take oral medications or needing intravenous nutrition
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 |
|---|---|---|
| Escalated: Inhomogeneous dose plan | Radiation | Escalation: Inhomogeneous dose plan |
| Standard: Homogeneous dose plan | Radiation | Standard: Homogeneous dose plan |
Primary outcome
Locoregional control (Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen)
Time frame: 5-7 years
Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen ) every 3 months combined with PET/CT every 9 months or if occurrence is clinically suspected. Suspicion of tumor relapse local, regional or distant should be verified by biopsy. Date of detected recurrence is the date of the imaging modality suspecting relapse. The patient will be censured at death without local relapse.
3 secondary outcomes
Toxicity (graded after CTCAE 4.0 assessed by physician)
Time frame: 10 years
Survival
Time frame: 15 years
Progression free survival
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 40249893Schytte T, Knap MM, Kristiansen C, Appelt AL, Khalil A, Peucelle C, Lutz CM, Moller DS, Sande EPS, Sundby F, Persson G, Schmidt H, Land LH, Rogg L, Pohl M, Lund MD, Nielsen M, Levin N, Hansen O, Thing RS, Borissova S, Halvorsen T, Nielsen TB, Hansen TS, Haakensen VD, Ottosson W, Brink C, Hoffmann L. Toxicity Within 6 Months of Heterogeneous Fluorodeoxyglucose-Guided Radiotherapy Dose Escalation for Locally Advanced Non-Small Cell Lung Cancer in the Scandinavian Randomized Phase III NARLAL2 Trial. J Clin Oncol. 2025 Jun 10;43(17):1972-1983. doi: 10.1200/JCO-24-01386. Epub 2025 Apr 18.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escalated: Inhomogeneous dose plan and Standard: Homogeneous dose plan in people with NSCLC, run by Olfred Hansen at 7 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olfred Hansen, MD (+4565411867, olfred.hansen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional control (Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen) (time frame: 5-7 years). 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 NCT02354274, 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 25 Apr 2022.