Clinical Database of Safe Personalized Adjuvant Breast Radiotherapy Based on Individual Radiosensitivity
Recruiting · NCT04282122 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Severe but also moderate toxicities after curative-intent radiotherapy (RT), such as a poor cosmetic outcome following breast cancer can have a negative impact on quality of life and a marked effect on subsequent psychological outcome. Nevertheless, current practice standards commonly prescribe radiation dose and volume without regard to individual radiosensitivity. In that context, a normal tissue radiosensitivity test that includes a rapid (72 h) radiosensitivity assay based on flow cytometric assessment of radiation-induced CD8 T-lymphocyte apoptosis (RILA) and other significant clinical parameters (multifactorial nomogram) was developed. Omission of radiotherapy has been suggested when luminal A tumor subtype is combined with clinical and pathologic factors defining a subgroup of patients with a low risk of ipsilateral breast recurrence. In this group, the benefits of radiotherapy are small \[6\]. Reduction of the breast irradiated volume is also a possibility that has been tested and published using IORT, brachytherapy or external beam radiotherapy. Hypofractionation has been adapted to breast cancer radiotherapy. Overall, all recent clinical trials \[13, 14\] showed only few late effects when hypofractionation was delivered to the whole breast (WB). These results reinforce the need of patients' selection using the NovaGray Breast® test. Our hypothesis is therefore that the different techniques (volume reduction or hypofractionation) as well as radiotherapy omission will significantly reduce grade ≥2 bf+ in a personalized approach (driven by a predictive assay of late effects) compared to WB hypofractionation in a selected population at low risk of breast recurrence. We would like to establish a prospective evaluation of daily practice including the individual radiosensitivity test to the decision of daily practice
Who can take part
Inclusion criteria
- Compliant women ≥ 65 years old.
- Conservative breast cancer surgery.
- T1-T2; N sentinel negative/N0.
- Luminal A tumors.
- Tumor negative margins.
- Indication of whole breast irradiation only.
- Extension evaluation of disease will be proven negative (M0).
- Must be geographically accessible for follow-up.
- Written and dated informed consent.
- Affiliated to the French social security system.
Exclusion criteria
- Patients with distant metastases.
- Indications of node irradiation.
- Synchronous bilateral breast cancer.
- Patients treated by radical mastectomy.
- Patients with neoadjuvant therapy.
- Patients with previous or concomitant other (not breast cancer) malignancy within the past 3 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least three years.
- Patients with other unstable or untreated non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.
- Patients treated with systemic investigational drugs within the past 30 days
Where it is running
1 location listed.
- Institut Régional du Cancer de Montpellier - Montpellier, Occ, France