Status:
UNKNOWN
Pilot Study of 18F-FAZA in Assessing Early Functional Response in Patients With Inoperable Non Small Cell Lung Cancer Undergoing Radiotherapy or Chemo-radiotherapy
Lead Sponsor:
AHS Cancer Control Alberta
Conditions:
Lung Neoplasm
Cell Hypoxia
Eligibility:
All Genders
18+ years
Brief Summary
Non-small cell lung cancer (NSCLC) has a poor prognosis if not caught early enough. One of the factors that may impact the ability to control NSCLC is low oxygen levels (hypoxia) inside the tumour. Th...
Detailed Description
Locally advanced NSCLC has a poor prognosis with a 5 year overall survival rate of only 15%. Tumour hypoxia may impact the ability to control NSCLC. Using 18F-FAZA PET, this study will assess patients...
Eligibility Criteria
Inclusion
- Patients with histologically-proven, by biopsy or cytology, unresected lung cancer of the following histological types: squamous cell carcinoma; adenocarcinoma; undifferentiated large cell carcinoma, and non-small cell, not otherwise specified (NOS, diagnosis on cytology alone)
- Patients with American Joint Committee on Cancer (AJCC) Stage I, II, IIIA, or IIIB with detectable tumour that can be encompassed by radiation therapy fields, including both primary tumour and the involved regional lymph nodes.
- Patients must be deemed to be suitable to undergo definitive (i.e. potentially curable) chemoradiotherapy or radiotherapy by the treating Physician.
- The prescribed radiotherapy dose must be a minimum of 60 Gy in 30 fractions
- Male or female ≥ 18 years of age. If female of child bearing potential and outside the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
- ECOG/Zubrod status 0-1
- Patients must have at least one measurable lesion ≥ 1 cm on CT
- Able and willing to follow instructions and comply with the protocol
- Provide written informed consent prior to participation in the study
Exclusion
- Patients who have undergone complete or subtotal tumour resection
- Patients with post-resection intrathoracic tumour recurrence
- Patients eligible for definitive surgery (patients who are eligible for surgery, but surgery did not proceed are eligible for this trial)
- No distant or metastasis, prior chemotherapy, or thoracic neck or radiotherapy
- Evidence of any small cell histology
- Prior or concurrent malignancy (except non-melanomatous skin cancer) unless disease-free for at least 5 years
- Inability to lay in supine position for approximately one hour
- Nursing or pregnant females
- Aged less than 18 years
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00765986
Start Date
October 1 2008
End Date
October 1 2015
Last Update
October 3 2014
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada