Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)
N/A
N/A
Both
Breast Cancer, Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Prostate Cancer, Sarcoma, Vaginal Cancer, Vulvar Cancer
Trial Information
Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Safety Issue:
No
Principal Investigator
Catherine West
Investigator Role:
Study Chair
Investigator Affiliation:
Christie Hospital NHS Foundation Trust
Authority:
Unspecified
Study ID:
CDR0000581139
NCT ID:
NCT00601406
Start Date:
March 2006
Completion Date:
Related Keywords:
- Breast Cancer
- Cervical Cancer
- Endometrial Cancer
- Fallopian Tube Cancer
- Ovarian Cancer
- Prostate Cancer
- Sarcoma
- Vaginal Cancer
- Vulvar Cancer
- 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 uterine sarcoma
- stage II uterine sarcoma
- stage III uterine sarcoma
- stage IV uterine sarcoma
- fallopian tube cancer
- stage I vaginal cancer
- stage II vaginal cancer
- stage III vaginal cancer
- stage IVA vaginal cancer
- stage IVB vaginal cancer
- stage I vulvar cancer
- stage II vulvar cancer
- stage III vulvar cancer
- stage IV vulvar cancer
- stage I ovarian epithelial cancer
- stage I ovarian germ cell tumor
- stage II ovarian epithelial cancer
- stage II ovarian germ cell tumor
- stage III ovarian epithelial cancer
- stage III ovarian germ cell tumor
- stage IV ovarian epithelial cancer
- stage IV ovarian germ cell tumor
- stage I endometrial carcinoma
- stage II endometrial carcinoma
- stage III endometrial carcinoma
- stage IV endometrial carcinoma
- ovarian stromal cancer
- ovarian sarcoma
- Breast Neoplasms
- Endometrial Neoplasms
- Uterine Cervical Neoplasms
- Ovarian Neoplasms
- Prostatic Neoplasms
- Vaginal Neoplasms
- Vulvar Neoplasms
- Fallopian Tube Neoplasms
- Adenoma
- Sarcoma
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