NCT00572325CompletedNot Applicable
Concurrent Chemo-radiotherapy for Stage III Non-small Cell Lung Cancer ta an Individualized MLD
Maastricht Radiation Oncology1 site in 1 country180 target enrollmentStarted: August 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- death
Study Overview
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 patients with non-concurrent chemo-radiation. In a subsequent phase I trial, in patients receiving non-concurrent chemo-radiation we showed the safety of this approach. Here,we want to investigate its efficacy in a prospective study in patients with stage III NSCLC, who are selected for radical concurrent 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:54 Gy. Maximal tumor dose:69 Gy
Radiotherapy will be delivered as follows:
- First 3 weeks: 30 fractions: twice-daily fractions of 1.5 Gy, with 8 to 10 h as interfraction-interval, 5 days per week Total dose;45Gy/30 fractions
- Thereafter: once-daily fractions of 2.0 Gy, 5 days per week until the target dose has been reached.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
death
Time Frame: 2,3 and 5 years
Secondary Outcomes
- -progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -Patterns of recurrence(2,3 and 5 years)
Investigators
Study Sites (1)
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