Effect of Radiotherapy Variables on Circulating Effectors of Immune Response and Local Microbiome

NCT03383107 | Completed

• 1 other identifier: 1708018471
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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 decrease in immune cells. To test this hypothesis, investigators will take blood samples from subjects undergoing two different standard of care radiation regimens for prostate cancer, and subjects undergoing two different standard of care regimens for breast cancer.

Conditions

Breast Cancer; Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• prospectively collecting blood specimens to assess peripheral immune mediatiors in 4 distinct clinical settings

  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)

  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

  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 Outcomes (1)

• microbiome changes associated with different radiation treatments through collection of stool microbiome samples at different time points

  4 years

Study Arms (4)

Cohort 1a - Prostate Cancer

Standard fractionation RT to 81 Gy in 45 fx over 9 weeks

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

Cohort 2b - Breast Cancer (Partial Breast )

Partial breast RT to 30 Gy in 5 fx over 2 weeks

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Biopsy-proven diagnosis of prostate adenocarcinoma
• Age ≥ 18

You may not qualify if:

• 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
• Biopsy-proven diagnosis of invasive breast cancer, s/p breast surgery to negative margins, and requiring adjuvant breast and nodal RT
• Age ≥ 18
• 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
• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Publications (2)

• 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.

  PMID: 23291374 BACKGROUND

• 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.

  PMID: 23078897 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood specimens will be collected prospectively from consented patients at baseline, during radiation therapy, at completion of radiation therapy and during 3-4 month follow up visit.

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Silvia Formenti, M.D.

  Weill Cornell Medicine - New York Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 26, 2017
• Study Start: January 22, 2018
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)