Status:
COMPLETED
Effect of Radiotherapy Variables on Circulating Effectors of Immune Response and Local Microbiome
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Varian Medical Systems
Conditions:
Breast Cancer
Prostate Cancer
Eligibility:
All Genders
18-90 years
Brief Summary
Exposure to radiation can impact immune cells that are present in the blood, such as lymphocytes. It is hypothesized that larger radiation fields and/or longer courses of radiation, result in greater ...
Detailed Description
The study prospectively collects blood specimens for assessment of peripheral immune mediators in 4 distinct clinical settings of standard radiotherapy. In addition to collecting blood specimens, the ...
Eligibility Criteria
Inclusion
- Cohort 1a and b: Prostate cancer subjects undergoing 9 week radiation
- Inclusion criteria:
- Biopsy-proven diagnosis of prostate adenocarcinoma
- Age ≥ 18
- Exclusion criteria:
- History of prior pelvic radiation (external beam or brachytherapy)
- Prior or concurrent lymphomatous/hematogenous malignancy, or history of prior/concurrent invasive malignancy during the past 5 years
- History of hormone therapy such as LHRH agonists (gosrelin, leuprolide), anti-androgens (flutamide, bicalutamide), surgical castration (orchiectomy)
- History of irritable bowel disease
- Evidence of lymph node involvement or metastatic disease
- Cohort 2a : Breast cancer subjects undergoing standard fractionation RT of 5 weeks
- Inclusion criteria:
- Biopsy-proven diagnosis of invasive breast cancer, s/p breast surgery to negative margins, and requiring adjuvant breast and nodal RT
- Age ≥ 18
- Exclusion criteria:
- History of prior radiation therapy to the ipsilateral breast
- Prior or concurrent lymphomatous/hematogenous malignancy, or history of prior/concurrent invasive malignancy during the past 5 years
- \< 1 month from completion of chemotherapy to start of RT
- Evidence of metastatic disease
- Cohort 2b: Breast cancer subjects undergoing PBI
- Inclusion criteria:
- Post-menopausal women defined as either 1) at least 2 years without menstrual period or 2) or patients older than 50 with serological evidence of post-menopausal status or 3) hysterectomized patients of any age with FSH confirmation of post-menopausal status.
- Post-segmental mastectomy with negative margins
- If bilateral, pT1 breast cancer, excised with negative margins AND/OR
- pTis excised with negative margins
- Clinically N0 or pN0 or sentinel node negative
- Diagnosis of ductal carcinoma in situ DCIS, limited to \<2cm size of DCIS and to lesions of low or intermediate grade, excised (or re-excised) with final negative margins ( no DCIS on inked margins).
- Age ≥ 18
- Exclusion criteria:
- History of prior radiation therapy to the ipsilateral breast
- Presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC).
- \< 1 month from completion of chemotherapy to start of RT
- Evidence of metastatic disease
Exclusion
Key Trial Info
Start Date :
January 22 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03383107
Start Date
January 22 2018
End Date
July 31 2021
Last Update
August 12 2022
Active Locations (1)
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1
Weill Cornell Medical College
New York, New York, United States, 10065