Status:
COMPLETED
Hypofractionated Radiotherapy for Small Cell Lung Cancer
Lead Sponsor:
AHS Cancer Control Alberta
Collaborating Sponsors:
Cross Cancer Institute
Conditions:
Lung Neoplasm
Small Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Current treatments for limited stage small cell lung cancer have poor cure rates. The addition of chest radiation to chemotherapy improves cure rates, but these cancers still come back in the chest 30...
Detailed Description
Local control and overall survival rates associated with the standard chemotherapy and radiotherapy given for limited stage small cell lung cancer are poor and emerging evidence from several studies s...
Eligibility Criteria
Inclusion
- patients with histologically or cytologically proven newly diagnosed small cell lung cancer
- confirmation from the treating radiation oncologist that the patient has limited stage disease (i.e. disease that can be encompassed by radiotherapy portals without exposing patient to excessive risk of radiation lung injury)
- adequate pulmonary function tests (FEV-1 \>1.0, DLCO \>50%)
- patients of childbearing potential must practice adequate contraception
- age greater than 18 years
- Karnofsky performance status greater than 70
- adequate hematologic, hepatic and renal function: Hb\>100g/L, WBC \> 4.0x109/L, neutrophils \> 1.0x109/L, platelets \> 100,000x109/L, calculated GFR based on Cockcroft-Gault formula of \>60mL/min (NOTE: for cisplatin, GFR must be above 60ml/min; if less than 60ml/min the patient can not receive cisplatin but could be considered for carboplatin)
- patients must sign a study specific informed consent form
Exclusion
- patient who have undergone complete or subtotal tumour resection
- evidence of non-small cell histology
- pericardial or pleural effusion on radiologic investigations regardless of cytology
- patients cannot be treated with 3DCRT with adherence to the dose volume constraints
- prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
- prior radiotherapy to the thorax or neck
- prior chemotherapy
- patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure, uncontrolled arrhythmias
- compromised lung function with inadequate pulmonary function tests (FEV-1\<1.0, DLCO \<50%)
- pregnancy (patients with childbearing potential must practice appropriate contraception)
- patients who have not had the pre-treatment evaluations outlined in the protocol
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00469222
Start Date
March 1 2007
End Date
April 1 2011
Last Update
February 25 2016
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2