Radiotherapy for NSCLC to a Individualized MLD

NCT ID: NCT00573040

Last Updated: 2010-07-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2008-06-30

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht Radiation Oncology

OTHER

Sponsor Role: lead

Responsible Party

MAASTRO clinic

Principal Investigators

Dirk De Ruysscher, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

MAASTRO clinic, Maastricht Radiation Oncology

Locations

MAASTRO clinic, Maastricht Radiation Oncology

Maastricht, Limburg, Netherlands

Countries

Netherlands

References

Nalbantov G, Kietselaer B, Vandecasteele K, Oberije C, Berbee M, Troost E, Dingemans AM, van Baardwijk A, Smits K, Dekker A, Bussink J, De Ruysscher D, Lievens Y, Lambin P. Cardiac comorbidity is an independent risk factor for radiation-induced lung toxicity in lung cancer patients. Radiother Oncol. 2013 Oct;109(1):100-6. doi: 10.1016/j.radonc.2013.08.035. Epub 2013 Sep 14.

Reference Type: DERIVED

PMID: 24044794 (View on PubMed)

Dehing-Oberije C, Aerts H, Yu S, De Ruysscher D, Menheere P, Hilvo M, van der Weide H, Rao B, Lambin P. Development and validation of a prognostic model using blood biomarker information for prediction of survival of non-small-cell lung cancer patients treated with combined chemotherapy and radiation or radiotherapy alone (NCT00181519, NCT00573040, and NCT00572325). Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):360-8. doi: 10.1016/j.ijrobp.2010.06.011. Epub 2010 Oct 1.

Reference Type: DERIVED

PMID: 20888135 (View on PubMed)

Other Identifiers

BRONC MLD

Identifier Type: -

Identifier Source: org_study_id