New radiation therapy approach for advanced lung cancer with Navelbine®
Novel Approach to Radiotherapy in Locally Advanced Lung Cancer - Heterogeneous FDG-guided Dose Escalation With Concomitant Navelbine®
This study is testing a new way of giving radiation therapy to see if targeting higher doses to specific areas can help people with advanced lung cancer feel better compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Aalborg and 6 other locations) |
| Trial ID | NCT02354274 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of escalating radiation doses to tumors and lymph nodes in patients with locally advanced non-small cell lung cancer (NSCLC). It compares an inhomogeneous dose distribution, guided by FDG-PET positive areas, to a standard homogeneous dose spread. The goal is to determine if this targeted approach can improve treatment outcomes. Patients will receive either the escalated or standard radiation treatment as part of their care plan.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically or cytologically proven locally advanced NSCLC stage IIB to IIIB and a performance status of 0-1.
Not a fit: Patients with unstable systemic disorders or those requiring nasal oxygen may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatment options for patients with advanced lung cancer.
How similar studies have performed: Other studies have explored similar approaches to radiation therapy, but this specific method of dose escalation based on FDG-PET imaging is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aalborg and 6 other locations
- 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)
Study contacts
- Study coordinator: Olfred Hansen, MD
- Email: olfred.hansen@rsyd.dk
- Phone: +4565411867
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.