Radiotherapy for NSCLC to a Individualized MLD (BRONC MLD)

Maastricht Radiation Oncology

Status: Completed

Conditions: Non-small Cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00573040

BRONC MLD

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological or cytological proven NSCLC
• UICC stage I-III
• Performance status 0-2
• FeV 1 and DLCO at least 30% of the age-predicted value

Exclusion criteria

• Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
• UICC stage IV
• Performance status 3 or more
• FeV 1 and DLCO < 30% of the age-predicted value

Trial design

180 participants in 1 patient group

1

Description:

Inclusion criteria * Histological or cytological proven NSCLC * UICC stage I-III * Performance status 0-2 * FeV1 and DLCO at least 30% of age-predicted value Exclusion criteria: * Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma) * Stage IV * Performance status 3 or more * FeV 1 or DLCO \< 30% of the age-predicted value