NCT00573040

Radiotherapy for NSCLC to a Individualized MLD

Radiotherapy for Stage I-III Non-small Cell Lung Cancer to an Individualized MLD

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Maastricht Radiation Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Our group has shown in a modeling study that increasing the radiation dose to pre-specified normal tissue dose constrains could lead to increased TCP with the same NTCP. In a subsequent phase I trial, the investigators showed the safety of this approach. Here, the investigators want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC, who are selected for radical radiotherapy

Detailed description

Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to the following MLD (Mean Lung Dose): * MLD=19 Gy when Fev1 and DLCO \> 50% of the predicted value * MLD=15 Gy when Fev1 and/or DLCO 40-49% of the predicted value * MLD=10 Gy when Fev1 and/or DLCO \<40% of the predicted value Other dose-constrains: spinal cord max: 54 Gy, brachial plexus (Dmax):66 Gy Minimum tumor dose:79.2 Gy. Radiotherapy will be delivered in twice-daily fractions of 1.8 Gy with 8 to 10 h as interfraction-interval, 5 days per week. The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.

Conditions

• Non-small Cell Lung Cancer

Timeline

• Start date: 2005-08-01
• Completion: 2008-06-01
• First posted: 2007-12-13
• Last updated: 2010-07-21

Locations

1 site across 1 country: Netherlands