Study of DNA Mutations in Predicting the Effect of External-Beam Radiation Therapy in Patients With Early Breast Cancer, Localized Prostate Cancer, or Gynecological Cancer | Recruiting
Study of DNA Mutations in Predicting the Effect of External-Beam Radiation Therapy in Patients With Early Breast Cancer, Localized Prostate Cancer, or Gynecological Cancer

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Breast Cancer
  • Cervical Cancer
  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • Prostate Cancer
  • Sarcoma
  • Vaginal Cancer
  • Vulvar Cancer
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruiting
Recruitment Status
NCT00601406
Primary Trial ID Number
Summary
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This clinical trial is evaluating DNA mutations in predicting the effect of external-beam radiation therapy in patients with early breast cancer, localized prostate cancer, or gynecologic cancer.
Research Details
  • OBJECTIVES: Primary - To test the hypothesis that an association between common genetic variations, reported by single nucleotide polymorphisms (SNP) in relevant candidate genes, is associated with individual patient variability in normal tissue radiation response and toxicity. Secondary - To compare different clinical scoring systems for late normal tissue effects, specifically Late Effect of Normal Tissue Subjective Objective Management Analysis (LENT SOMA), Radiation Therapy Oncology Group (RTOG), quality of life, and in a subset common terminology criteria (CTC) version 3. - To compare clinical scoring systems with analytical measures of normal tissue outcome in a minority of patients, using volume change in the breast measured by laser camera. - To correlate family history information with SNP analysis to produce a polymorphism risk score (PRS) for family history. - To compare a detailed 3D dose-volume analysis in a subset of patients with late effects and SNP results. - To correlate actuarial analysis of late effects changes over time with PRS. - To conduct PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability. OUTLINE: This is a multicenter study. Patients are recruited from clinical trials in which their late normal tissue effects have been measured. Blood samples are collected from these patients for analysis of genetic variation by DNA extraction and single nucleotide polymorphism analysis. Sixty different genes, including those involved in cell cycle checkpoint control, DNA damage recognition and repair, induction of apoptosis, and cytokine production (including TGFβ pathways) are assessed.
Phase
N/A
Study Design
Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Genetic : gene expression analysis, Genetic : gene rearrangement analysis, Genetic : polymorphism analysis, Other : laboratory biomarker analysis, Radiation : radiation therapy

Study Arm Groups : , , , ,

Intervention Type
See Interventions above
Primary Outcome Measures
  • Correlation of association between common genetic variations, reported by single nucleotide polymorphisms (SNP) in relevant candidate genes, with individual patient variability in normal tissue radiation response and toxicity; null
Secondary Outcome Measures
  • Comparison of different clinical scoring systems for late normal tissue effects; null; Comparison of clinical scoring systems with analytical measures of normal tissue outcome using volume change in the breast measured by laser camera; null; Correlation of family history information with SNP analysis to produce a polymorphism risk score (PRS); null; Comparison of detailed 3D dose-volume analysis with late effects and SNP results; null; Correlation of actuarial analysis of late effects changes over time with PRS; null; PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability; null
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
N/A - N/A
Who Can Participate
Patients
Number of Participants
2200
Participant Inclusion Criteria
  • DISEASE CHARACTERISTICS:
  • - Patients must have received curative external-beam radiotherapy within the context of
  • a formal clinical study for any of the following:
  • - Early breast cancer after breast-conserving surgery
  • - Localized prostate cancer
  • - Gynecological cancer (may have also received brachytherapy)
  • - Venous blood samples must be available
  • - Patients will be identified from the following clinical studies:
  • - Cambridge intensity-modulated radiotherapy breast randomized trial
  • - RT01 prostate radiotherapy randomized trial/other prostate trials
  • - Christie hospital breast, prostate, and gynecological cancer radiotherapy
  • patients
  • - Must have minimum follow up with late normal tissue effect scoring for two years
  • available
  • PATIENT CHARACTERISTICS:
  • - No other malignancy prior to treatment for the specified tumor types except basal
  • cell or squamous cell carcinoma of the skin or in situ carcinoma
  • PRIOR CONCURRENT THERAPY:
  • - See Disease Characteristics
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Addenbrooke's Hospital
Cambridge
England
CB2 2QQ
Christie Hospital NHS Foundation Trust
Manchester
M20 4BX
GSK Investigational Site
Ipswich
IP4 5PD
Research Site
Sutton
Surrey
SM2 5PT
Clatterbridge Centre for Oncology
Merseyside
England
CH63 4JY
Pfizer Investigational Site
Brighton
BN2 5BE
Weston Park Hospital
Sheffield
England
S1O 2SJ
Bristol Haematology & Oncology Centre
Bristol
BS2 8ED
St Helens & Knowsley Teaching NHS Trust
Prescot
Merseyside
L35 5DR
Warrington Hospital NHS Trust
Warrington
England
WA5 1QG
Southport and Formby District General Hospital
Southport
England
PR8 6PN
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CDR0000581139
Sponsor(s)
Christie Hospital NHS Foundation Trust
Key Dates

Recruitment Start Date

Mar 2006

Recruitment End Date

Feb 2008

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

25 Jan 2008

Last Updated

23 Aug 2013