Clinical trial · Observational
Effect of Radiotherapy Variables on Circulating Effectors of Immune Response and Local Microbiome
NCT03383107CI-TRIAL-00060309completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- Cohort 1a - Prostate Cancer
- description
- Standard fractionation RT to 81 Gy in 45 fx over 9 weeks
- label
- Cohort 1b - Prostate Cancer
- description
- Hypofractionated RT to 36.25 Gy in 5 fx over 1-2 weeks
- label
- Cohort 2a - Breast cancer
- description
- Standard fractionation breast and nodal RT to 50 Gy in 25 fx over 5 weeks
- label
- Cohort 2b - Breast Cancer (Partial Breast )
- description
- Partial breast RT to 30 Gy in 5 fx over 2 weeks
Primary outcomes (2)
- measure
- prospectively collecting blood specimens to assess peripheral immune mediatiors in 4 distinct clinical settings
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDFormenti 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
- BACKGROUNDFormenti 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