Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.
August 1, 2008 updated by: AZ-VUB
Phase II Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.
The study population will exist of patients with a histological diagnosis of NSCLC, stage T1, T2 or T3NO who are not fit for or who refuse surgery.
A prospective data analysis will be performed on tumor response, potential acute and late toxicity and survival.
A radiotherapy dose of 4x15Gy or 3x 20Gy will be given over 2 weeks with dynamic 3D-conformal arc therapy (Novalis TM)
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
44
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Brussels
-
Jette, Brussels, Belgium, 1090
- Recruiting
- UZ Brussel
-
Contact:
- Samuel Bral, MD
- Phone Number: 003224763435
- Email: samuel.bral@uzbrussel.be
-
Principal Investigator:
- Samuel Bral, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology
- Maximal tumor diameter of 6 cm
- Only T3 lesions based upon thoracic wall involvement
- Informed consent is required
- Life expectancy of at least 6 months
- Age > 18 y.
- Karnofsky score ≥ 70 or ECOG score ≤ 1
- Inoperable patients or patients refusing surgery
- Patients with measurable lesion (according to RECIST criteria)
Exclusion Criteria:
- Diagnosis of small cell lung cancer
- Lymph node involvement
- Prior radiotherapy or chemotherapy for lung cancer
- Pregnant or lactating women
- Known allergy for CT contrast
- No FDG-PET
- Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
- Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, extreme degradation of lung function tests and patients not likely to complete the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
For centrally located T1 and T2 lesions 4 x 15 Gy over 2 weeks will be delivered.
Lesions located peripherally will be treated with 3 x 20 Gy, also delivered within 2 weeks.
For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions.
There should be a maximum of 2 fractions per week.
|
For centrally located T1 and T2 lesions 4 x 15 Gy over 2 weeks will be delivered.
Lesions located peripherally will be treated with 3 x 20 Gy, also delivered within 2 weeks.
For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions.
There should be a maximum of 2 fractions per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To monitor potential acute and late toxicity in patients with stage T1,T2,T3N0 non small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT).
Time Frame: Every 3 months for the first 2 years. From 3 to 5 years every 6 months. After 5 years follow-up will happen yearly.
|
Every 3 months for the first 2 years. From 3 to 5 years every 6 months. After 5 years follow-up will happen yearly.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Local control at 2 years. Overall survival, local progression free survival, disease free survival, time to progression and local,regional or disseminated recurrence.Quality of life. Internal and Intra-fractional tumor motion. Biopsy samples.
Time Frame: Every 3 months for the first 2 years. From 3 to 5 years every 6 months. After 5 years follow-up will happen yearly.
|
Every 3 months for the first 2 years. From 3 to 5 years every 6 months. After 5 years follow-up will happen yearly.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (ANTICIPATED)
March 1, 2012
Study Completion (ANTICIPATED)
December 1, 2012
Study Registration Dates
First Submitted
July 31, 2008
First Submitted That Met QC Criteria
August 1, 2008
First Posted (ESTIMATE)
August 4, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
August 4, 2008
Last Update Submitted That Met QC Criteria
August 1, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBRT-NSCLC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.