Establishment of a Prospective Evaluation of Daily Practice Including the Individual Radiosensitivity Test to the Decision of Daily Practice

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Institut Régional du Cancer de Montpellier
RECRUITING
Montpellier
Contact Information
Primary
Jean-Pierre BLEUSE, MD
DRCI-icm105@icm.unicancer.fr
0467613102
Time Frame
Start Date: 2019-05-23
Estimated Completion Date: 2026-06
Participants
Target number of participants: 500
Related Therapeutic Areas
Sponsors
Leads: Institut du Cancer de Montpellier - Val d'Aurelle

This content was sourced from clinicaltrials.gov