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Completed

NCT Number: NCT00573040

Radiotherapy for NSCLC to a Individualized MLD

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

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MAASTRO clinic, Maastricht Radiation Oncology

Maastricht, Limburg, 6202 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. death

    Time frame: 2,3 and 5 years

Secondary outcomes

  1. -progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -Patterns of recurrence

    Time frame: 2,3 and 5 years

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Registry information

Official study title

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

Acronym: BRONC MLD

Important dates

Study start
2005
Study completion
2008
First posted
Dec 13, 2007
Registry last updated
Jul 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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