Clinical trial · Interventional
Novel Approach to Radiotherapy in Locally Advanced Lung Cancer Concomitant Navelbine®
Novel Approach to Radiotherapy in Locally Advanced Lung Cancer - Heterogeneous FDG-guided Dose Escalation With Concomitant Navelbine®
NCT02354274CI-TRIAL-00058013recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Escalated: Inhomogeneous dose plan | Radiation | — | UNRESOLVED |
| Standard: Homogeneous dose plan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard: Homogeneous dose plan
- description
- Treatment will be given over 33 treatments. The dose is 66 Gy.
- interventionNames
- Radiation: Standard: Homogeneous dose plan
- type
- EXPERIMENTAL
- label
- Escalation: Inhomogeneous dose plan
- description
- 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
- interventionNames
- Radiation: Escalated: Inhomogeneous dose plan
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDSchytte 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. PMID 40249893