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

Olfred Hansen

Status: Enrolling

Conditions: NSCLC

Treatments: Radiation: Escalated: Inhomogeneous dose plan; Radiation: Standard: Homogeneous dose plan

Study type: Interventional

Funder types: Other

Identifiers

NCT02354274

NARLAL 2

Details and patient eligibility

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

Full 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.

Enrollment: 330 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

330 participants in 2 patient groups

Standard: Homogeneous dose plan

Active Comparator group

Description:

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

Treatment:

Radiation: Standard: Homogeneous dose plan

Escalation: Inhomogeneous dose plan

Experimental group

Description:

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

Treatment:

Radiation: Escalated: Inhomogeneous dose plan