NCT05045287

Hypofractionated Post Mastectomy Radiation With Two-Stage Expander/Implant Reconstruction

Phase II Study of Hypofractionated Post Mastectomy Radiation With Two-Stage Expander/Implant Reconstruction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Hypofractionated radiotherapy could provide more convenient treatment and had similar toxicities.However,reports of hypofractionated radiotherapy with two-stage expander/implant reconstruction are rare,Some studies have shown that hypofractionated radiotherapy had similar toxicities to conventional fractionated radiotherapy in patients with breast reconstruction. So,investigators conducted a phase II study to observe the reconstruction failure in hypofractionated radiotherapy with two-stage expander/implant reconstruction.

Detailed description

Results from a phase III randomized controlled study in China showed that Postmastectomy hypofractionated radiotherapy was non-inferior to and had similar toxicities to conventional fractionated radiotherapy in patients with high-risk breast cancer.However,reports of hypofractionated radiotherapy with two-stage expander/implant reconstruction are rare. Literatures report that reconstruction failure is a well-known complication of radiation therapy in breast cancer patients with reconstruction. Results may vary based on RT timing and technique. Some studies have shown that hypofractionated radiotherapy had similar reconstruction failure to conventional fractionated radiotherapy in patients with breast reconstruction. So,investigators conducted a phase II study to observe the reconstruction failure in hypofractionated radiotherapy with two-stage expander/implant reconstruction.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
RADIATION	hypofractionated radiotherapy	Undergo hypofractionated RT，obeserve reconstruction failure，cosmetic result and recurrence rate

Timeline

• Start date: 2021-04-08
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2021-09-16
• Last updated: 2021-09-16

Locations

1 site across 1 country: China