NCT02354274

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jan 2015Oct 2029

Study Start

First participant enrolled

January 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
14.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

14.8 years

First QC Date

January 19, 2015

Last Update Submit

April 22, 2022

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

  • 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.

    5-7 years

Secondary Outcomes (3)

  • Toxicity (graded after CTCAE 4.0 assessed by physician)

    10 years

  • Survival

    15 years

  • Progression free survival

    15 years

Study Arms (2)

Standard: Homogeneous dose plan

ACTIVE COMPARATOR

Treatment will be given over 33 treatments. The dose is 66 Gy.

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

Radiation: Escalated: Inhomogeneous dose plan

Interventions

Escalated: Inhomogeneous dose planRADIATION
Escalation: Inhomogeneous dose plan
Standard: Homogeneous dose planRADIATION
Standard: Homogeneous dose plan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Aalborg University Hospital

Aalborg, 9100, Denmark

NOT YET RECRUITING

Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

NOT YET RECRUITING

Herlev University Hospital

Herlev, 2730, Denmark

RECRUITING

Department of Oncology, Naestved Hospital

Næstved, Denmark

NOT YET RECRUITING

Department of Oncology, Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Department of Oncology, Vejle Hospital

Vejle, 7100, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40249893DERIVED

Central Study Contacts

Olfred Hansen, MD

CONTACT

+4565411867olfred.hansen@rsyd.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Two independent radiation plans are made before randomization to ensure best available plans for both arms and trial.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 19, 2015

First Posted

February 3, 2015

Study Start

January 1, 2015

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations

DK(7)