Radiotherapy for NSCLC to a Individualized MLD - Full Text View

Sponsored by:	Maastricht Radiation Oncology
Information provided by:	Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:	NCT00573040

Purpose

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

Condition
Non-Small Cell Lung Cancer

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Radiotherapy for Stage I-III Non-Small Cell Lung Cancer to an Individualized MLD

Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:

death [ Time Frame: 2,3 and 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

-progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -Patterns of recurrence [ Time Frame: 2,3 and 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	180
Study Start Date:	August 2005
Estimated Study Completion Date:	March 2008

Groups/Cohorts
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573040

Contacts

Contact: Dirk De Ruysscher, MD,PhD

+31(0)884455700

dirk.deruysscher@maastro.nl

Locations

Netherlands, Limburg
MAASTRO clinic, Maastricht Radiation Oncology	Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Dirk De Ruysscher, MD,PhD +31(0)884455700 dirk.deruysscher@maastro.nl
Principal Investigator: Dirk De Ruysscher, MD,Phd

Sponsors and Collaborators

Maastricht Radiation Oncology

Investigators

Principal Investigator:

Dirk De Ruysscher, MD,PhD

MAASTRO clinic, Maastricht Radiation Oncology

More Information

Responsible Party:	MAASTRO clinic ( MAASTRO clinic )
Study ID Numbers:	BRONC MLD
Study First Received:	December 12, 2007
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00573040
Health Authority:	Netherlands:Board MAASTRO clinic

Keywords provided by Maastricht Radiation Oncology:

Radiotherapy
NSCLC
Stage III non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009