This study will examine, for the first time, the independent contribution of a patient''''s own genetic makeup to the development of post-radiation complications, permitting in future the development of predictive tests to avoid radiation injury. To do this, we will examine gene markers in a series of approximately breast, prostate, brain and lung cancer survivors who have received conformal radiotherapy between 1996 and 2003 at the Cross Cancer Institute and Tom Baker Cancer Centre

Condition
-breast carcinoma -glioma -prostate carcinoma -squamous cell carcinoma of the head and neck -lung carcinoma (non-small cell)

Further Study Details: 

Expected Total Enrollment:  500

Major innovations in radiotherapy (RT) delivery (3D conformal RT, intensity modulated RT) now permit RT dose escalation to be tested as a means of improving disease control in many tumour sites. With delivery innovations, life-threatening toxicity occurs rarely, but significant clinical toxicity is common. In previous work we have studied a cohort of 98 prostate patients who received dose-escalated 3D-CRT and have obtained evidence of genetic and dosimetric factors underlying rectal/bladder toxicity. We posit that the late radiation toxicity disease state has significant genetic determinants in other malignancies. These determinants are neither understood nor accounted for in selection of treatment, and we propose to study additional well-characterized cohorts, who are clinically well from a disease control perspective, given that comprehensive dosimetric and outcome information is available on all.

For a thorough understanding of the molecular processes underlying tissue responses to radiation damage, we propose a genomic analysis. Our working hypothesis is that normal organ toxicity will be associated with patient genetics as measured by single nucleotide polymorphisms (SNPs) in a select group of genes. The criteria for selecting SNPs will be based on a candidate gene approach, choosing genes implicated or demonstrated in DNA repair pathways and radiation-induced tissue damage/tissue homeostasis. Analysis of these data will use both statistically based bioinformatics approaches.

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• breast cancer -prostate cancer -SCC head and neck -NSCLC -glioma treated by radiotherapy

Exclusion Criteria:

• follow up less than 18 months

Please refer to this study by ClinicalTrials.gov identifier  NCT00122239

Matthew Parliament, MD      780-432-8517    matthewp@cancerboard.ab.ca

Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada; Recruiting

Study chairs or principal investigators

Matthew Parliament, MD,  Principal Investigator,  Cross Cancer Institute   

Study ID Numbers:  SP-14-0043
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122239
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-07-26