BRONC MLD: Radiotherapy for NSCLC to a Individualized MLD

• Sponsor: Maastricht Radiation Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00573040
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Duration (Months): 34
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 180 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Radiotherapy for Stage I-III Non-small Cell Lung Cancer to an Individualized MLD
• Study Start Date: Aug 1, 2005
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. death [2,3 and 5 years]

Secondary Outcome Measures

1. -progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -Patterns of recurrence [2,3 and 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MAASTRO clinic, Maastricht Radiation Oncology	Maastricht	Limburg	Netherlands	6202 AZ

Sponsors and Collaborators

• Maastricht Radiation Oncology

Investigators

• Principal Investigator: Dirk De Ruysscher, MD,PhD, MAASTRO clinic, Maastricht Radiation Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00573040
• Other Study ID Numbers: BRONC MLD
• First Posted: Dec 13, 2007
• Last Update Posted: Jul 21, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Radiotherapy; NSCLC; Stage III non-small cell lung cancer
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jul 21, 2010