Status:
UNKNOWN
Individual Boosting in Non-Small Cell Lung Cancer Using Hypofractionation, Intensity-modulated Radiation Therapy and Respiratory Gating
Lead Sponsor:
AHS Cancer Control Alberta
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Patients who have inoperable non-small cell lung cancer are presently treated with chemotherapy and radiation therapy. Despite this combined approach, the vast majority of patients will have their can...
Detailed Description
All patients must have a satisfactory IMRT plan prior to starting radiation therapy, which will commence concurrently with chemotherapy. All patients will be treated to a minimum of 48 Gy in 20 daily ...
Eligibility Criteria
Inclusion
- Patients with histologically-proven, by biopsy or cytology, unresected lung cancer of the following histologic types: Squamous cell carcinoma, Adenocarcinoma, Undifferentiated large cell carcinoma, Non-Small cee; not otherwise specified (NOS, diagnosis on cytology alone)
- Patients with AJCC Stage II, IIIA or IIIB if all detectable tumour can be encompassed by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes
- Patient must be deemed to be suitable to undergo definitive chemo-radiotherapy by the treating Physician.
- Age \> = 18
- ECOG/Zubrod status 0-1
- Patients must have measurable disease on CT imaging
- Satisfactory granulocytes, platelets, bilirubin, AST and calculated creatinine clearance
- Dose volume constraints must be met
- Patient must be able to use the breath-held technique
Exclusion
- Patients who have undergone complete or subtotal tumour resection
- Patients with post-resection intrathoracic tumour recurrence
- Patients eligible for definitive surgery
- Evidence of any small cell histology
- Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
- Exudative pleural effusion, or pleural effusions with positive cytology. Minimal pleural effusions which are too small to safely tap (i.e. not visible on chest x-ray) are eligible.
- Patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure and uncontrolled arrhythmias
- Pregnant women are ineligible. Patients with childbearing potential must practice appropriate contraception
- Patients with FEV1 \<= 0.8. Patients with FEV1 \>0.8 and \<1.0 to be discussed with a Respiratory Physician
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00690963
Start Date
September 1 2008
End Date
October 1 2016
Last Update
April 6 2016
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2