Status:
COMPLETED
Safety Study of Individualised Radiation Dose Determination for Lung Cancer Patients.
Lead Sponsor:
Maastricht Radiation Oncology
Conditions:
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Radiotherapy is treatment of choice for inoperable lung cancer. Research has shown that the local control rate is low and the radiation often causes pneumonitis and/or esophagitis. To predict to lung...
Detailed Description
Radiotherapy is treatment of choice for inoperable lung cancer. Research has shown that the survival rate as well as the local control rate is low. If chemotherapy treatment is added it leads to a sli...
Eligibility Criteria
Inclusion
- Histologically proven non-small cell lung cancer
- UICC stage I-III
- WHO performance status 0-2
- Less than 10 % weight loss the last 6 months
- In case of previous chemotherapy, radiotherapy can start after a minimum of 21 days after the last chemotherapy course
- Reasonable lung function: FEV1 ³ 60 % of the predicted value
- No recent ( \< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
- No active peptic oesophagitis
- Life expectancy more than 6 months
- Measurable cancer
- Willing and able to comply with the study prescriptions
- 18 years or older
- Not pregnant and willing to take adequate contraceptive measures during the study
- Have given written informed consent before patient registration
- No previous radiotherapy to the chest
Exclusion
- Not non-small cell histology, e.g. mesothelioma, lymphoma
- Mixed pathology, e.g. non-small cell plus small cell cancer
- Malignant pleural or pericardial effusion
- Concurrent chemotherapy with radiation
- History of prior chest radiotherapy
- Recent ( \< 3 months) myocardial infarction
- Uncontrolled infectious disease
- Distant metastases (stage IV)
- Patients with active peptic oesophagitis in the last year.
- Less than 18 years old
- Pregnant or not willing to take adequate contraceptive measures during the study
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00181545
Start Date
December 1 2004
End Date
May 1 2008
Last Update
June 30 2009
Active Locations (1)
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1
Maastircht Radiation Oncology
Heerlen, Limburg, Netherlands, 6411 PC