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®

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02354274

Enrollment

330

Registered

2015-02-03

Start date

2015-01-31

Completion date

2029-10-31

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Brief 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

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.

Interventions

RADIATIONStandard: Homogeneous dose plan

RADIATIONEscalated: Inhomogeneous dose plan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

Two independent radiation plans are made before randomization to ensure best available plans for both arms and trial.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Locoregional control (Tumor recurrency is assessed by scheduled CT (of the thorax and upper abdomen)	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.

Secondary

Measure	Time frame	Description
Toxicity (graded after CTCAE 4.0 assessed by physician)	10 years	Acute and late toxicity graded after CTCAE 4.0 assessed by physician at scheduled follow-up visits
Survival	15 years	Time from randomization to exact date of death of any cause.
Progression free survival	15 years	Time from randomization to date of progression, death, or occurence of metastatic disease

Countries

Denmark

Contacts

Primary ContactOlfred Hansen, MD

olfred.hansen@rsyd.dk+4565411867

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026