Novel Approach to Radiotherapy in Locally Advanced Lung Cancer Concomitant Navelbine®

NCT02354274 · tracked via the Priya Life Science Denmark tracker

Sponsor

Olfred Hansen

Phase

Not applicable

Started

2015-01

Last updated

2022-04-25

Condition(s) studied

NSCLC

Investigational drug(s) / intervention(s)

Escalated: Inhomogeneous dose planStandard: Homogeneous dose plan

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

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.

Trial sites (7)

Facility	City	Region	Status
Aalborg University Hospital	Aalborg	Denmark	Not Yet Recruiting
Aarhus University Hospital	Aarhus	Denmark	Recruiting
Rigshospitalet	Copenhagen	Denmark	Not Yet Recruiting
Herlev University Hospital	Herlev	Denmark	Recruiting
Department of Oncology, Naestved Hospital	Næstved	Denmark	Not Yet Recruiting
Department of Oncology, Odense University Hospital	Odense	Denmark	Recruiting
Department of Oncology, Vejle Hospital	Vejle	Denmark	Recruiting

Other trials for the same condition

Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer Recruiting

Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02354274 on ClinicalTrials.gov ↗ ← All trials in Denmark