- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03383107
Effect of Radiotherapy Variables on Circulating Effectors of Immune Response and Local Microbiome
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10065
- Weill Cornell Medical College
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Men with biopsy-proven, non-metastatic prostate adenocarcinoma, meeting the inclusion/exclusion criteria below, and electing to undergo definitive radiation treatment, will be eligible for participation.
Women with biopsy-proven, non-metastatic invasive or in situ breast cancer meeting the inclusion/exclusion criteria below will be eligible for participation.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cohort 1a - Prostate Cancer
Standard fractionation RT to 81 Gy in 45 fx over 9 weeks
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Cohort 1b - Prostate Cancer
Hypofractionated RT to 36.25 Gy in 5 fx over 1-2 weeks
|
Cohort 2a - Breast cancer
Standard fractionation breast and nodal RT to 50 Gy in 25 fx over 5 weeks
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Cohort 2b - Breast Cancer (Partial Breast )
Partial breast RT to 30 Gy in 5 fx over 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prospectively collecting blood specimens to assess peripheral immune mediatiors in 4 distinct clinical settings
Time Frame: 4 years
|
prospectively collect collect physical and dosimetric information of treatment and sequential blood samples for assessment of peripheral immune mediators in 4 distinct clinical settings of standard radiotherapy (2 for breast and 2 for prostate cancer)
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4 years
|
distribution and frequency of peripheral immune mediators before, during and after radiotherapy will be assessed from blood samples that are collected at various time points
Time Frame: 4 years
|
To characterize the distribution and frequency of peripheral immune mediators before, during and after radiotherapy in each of the 4 subsets of the prospective trial.
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
microbiome changes associated with different radiation treatments through collection of stool microbiome samples at different time points
Time Frame: 4 years
|
explore microbiome changes associated with different radiation treatments through collection of stool microbiome samples at baseline, at the end of radiation therapy, and during follow up after completion of Radiotherapy
|
4 years
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Formenti SC, Demaria S. Combining radiotherapy and cancer immunotherapy: a paradigm shift. J Natl Cancer Inst. 2013 Feb 20;105(4):256-65. doi: 10.1093/jnci/djs629. Epub 2013 Jan 4.
- Formenti SC, Demaria S. Radiation therapy to convert the tumor into an in situ vaccine. Int J Radiat Oncol Biol Phys. 2012 Nov 15;84(4):879-80. doi: 10.1016/j.ijrobp.2012.06.020. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1708018471
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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