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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

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ClinicalTrials.gov Identifier: NCT00601406
Recruitment Status : Unknown
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : January 28, 2008
Last Update Posted : August 26, 2013
Sponsor:
Information provided by:

Study Description
Brief 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.


Condition or disease Intervention/treatment
Breast Cancer Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer Prostate Cancer Sarcoma Vaginal Cancer Vulvar Cancer Genetic: gene expression analysis Genetic: gene rearrangement analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Radiation: radiation therapy

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2200 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)
Study Start Date : March 2006
Estimated Primary Completion Date : February 2008


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Comparison of different clinical scoring systems for late normal tissue effects
  2. Comparison of clinical scoring systems with analytical measures of normal tissue outcome using volume change in the breast measured by laser camera
  3. Correlation of family history information with SNP analysis to produce a polymorphism risk score (PRS)
  4. Comparison of detailed 3D dose-volume analysis with late effects and SNP results
  5. Correlation of actuarial analysis of late effects changes over time with PRS
  6. PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601406


Locations
United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital Recruiting
Brighton, England, United Kingdom, BN2 5BE
Contact: Contact Person    44-12-7369-6955      
Bristol Haematology and Oncology Centre Recruiting
Bristol, England, United Kingdom, BS2 8ED
Contact: Contact Person    44-117-928-2415      
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Contact: Contact Person    44-1223-336-800      
Ipswich Hospital Recruiting
Ipswich, England, United Kingdom, IP4 5PD
Contact: Contact Person    44-1473-704-177      
Christie Hospital Recruiting
Manchester, England, United Kingdom, M20 4BX
Contact: Contact Person    44-161-446-8275      
Clatterbridge Centre for Oncology Recruiting
Merseyside, England, United Kingdom, CH63 4JY
Contact: Contact Person    44-151-334-1155      
Whiston Hospital Recruiting
Prescot, England, United Kingdom, L35 5DR
Contact: Contact Person    44-151-334-1155      
Cancer Research Centre at Weston Park Hospital Recruiting
Sheffield, England, United Kingdom, S1O 2SJ
Contact: Contact Person    44-114-226-5000      
Southport and Formby District General Hospital Recruiting
Southport, England, United Kingdom, PR8 6PN
Contact: Contact Person    44-151-334-1155      
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Contact Person    44-20-8661-3271      
Warrington Hospital NHS Trust Recruiting
Warrington, England, United Kingdom, WA5 1QG
Contact: Contact Person    44-151-334-1155      
Sponsors and Collaborators
The Christie NHS Foundation Trust
Investigators
Study Chair: Catherine West The Christie NHS Foundation Trust
More Information

ClinicalTrials.gov Identifier: NCT00601406     History of Changes
Other Study ID Numbers: CDR0000581139
CHNT-RAPPER
EU-20798
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: April 2008

Keywords provided by National Cancer Institute (NCI):
male breast cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IA cervical cancer
stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer
stage III cervical cancer
stage IVA cervical cancer
stage IVB cervical cancer
stage I vaginal cancer
stage II vaginal cancer
stage III vaginal cancer
stage IVA vaginal cancer
stage IVB vaginal cancer
stage IA vulvar cancer
stage IB vulvar cancer
stage II vulvar cancer
stage IIIC vulvar cancer
stage IIIA vulvar cancer
stage IIIB vulvar cancer
stage IVB vulvar cancer
stage IA ovarian epithelial cancer
stage IB ovarian epithelial cancer
stage IC ovarian epithelial cancer

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Sarcoma
Uterine Cervical Neoplasms
Fallopian Tube Neoplasms
Endometrial Neoplasms
Peritoneal Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Fallopian Tube Diseases
Adnexal Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases