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Radiotherapy for NSCLC to a Individualized MLD

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00573040
Acronym
BRONC MLD
Enrollment
180
Registered
2007-12-13
Start date
2005-08-31
Completion date
2008-06-30
Last updated
2010-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Radiotherapy, NSCLC, Stage III non-small cell lung cancer

Brief 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.

Interventions

None listed

Sponsors

Maastricht Radiation Oncology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
death2,3 and 5 years

Secondary

MeasureTime frame
-progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -Patterns of recurrence2,3 and 5 years

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026