Status:
WITHDRAWN
Hypoxia-guided Radiotherapy With Cisplatin-etoposide in Stage I-III : Small Cell Lung Cancer(SCLC)
Lead Sponsor:
Maastricht Radiation Oncology
Collaborating Sponsors:
Maastricht University Medical Center
Conditions:
Small Cell Lung Cancer (SCLC)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Since radiation dose escalation to a large volume of tumour inevitably will induce higher toxicity than is currently the case, efforts must be made to limit the volume of tissue irradiated. Moreover, ...
Detailed Description
Hypoxic imaging with PET scans seems attractive for this purpose as hypoxia is associated with resistance for radiotherapy and approximately 70 % of SCLC are severely hypoxic at diagnosis\[2\]. We hy...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed stage I-III small cell lung cancer. WHO performance status 0-2
- Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
- Adequate renal function: calculated creatinine clearance at least 40 ml/min
- Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution (in case of liver metastases ≤ 5 x ULN for the institution)
- No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
- Lung function: FEV1 at least 30 % and DLCO at least 30 % of the age predicted value
- No history of prior chest radiotherapy
- Life expectancy more than 6 months
- Willing and able to comply with the study prescriptions
- 18 years or older
- Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
- Ability to give and having given written informed consent before patient registration
- No mixed pathology, e.g. non-small cell plus small cell cancer
- No recent (\< 3 months) severe cardiac disease (NYHA class \>1) (congestive heart failure, infarction)
- No uncontrolled infectious disease
- No other active malignancy
- No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy) in previous 4 weeks
- No treatment with investigational drugs in 4 weeks prior to or during this study
Exclusion
- The opposite of the above
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01210131
Start Date
July 1 2013
End Date
August 1 2014
Last Update
August 27 2013
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