Novel Approach to Radiotherapy in Locally Advanced Lung Cancer Concomitant Navelbine®
Recruiting · NCT02354274 · Interventional (participants receive a specific treatment) · Lead sponsor: Olfred Hansen
View the official record on ClinicalTrials.gov →Interventions studied
Escalated: Inhomogeneous dose planStandard: Homogeneous dose plan
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
7 locations listed.
- Aalborg University Hospital - Aalborg, Denmark
- Aarhus University Hospital - Aarhus, Denmark
- Rigshospitalet - Copenhagen, Denmark
- Herlev University Hospital - Herlev, Denmark
- Department of Oncology, Naestved Hospital - Næstved, Denmark
- Department of Oncology, Odense University Hospital - Odense, Denmark
- Department of Oncology, Vejle Hospital - Vejle, Denmark