NCT02917421

Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations

Accelerated Radiation Therapy (ART) To The Breast And Nodal Stations After Neo-Adjuvant Systemic Therapy And Surgery: A Feasibility Study

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Female
• Age: 19 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This protocol is for patients with newly diagnosed breast cancer with an indication for post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.

Detailed description

Protocol has two cohorts. Cohort 1 will receive radiation to breast and chest wall. Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy x 15 fractions (40.50 Gy) with a concomitant boost of 0.50 (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost. Cohort 2 patients will receive radiation to breast, chest wall and LevelII/SCV nodes. In addition to receiving radiation to the original tumor bed, patients will also receive radiation to Level III axillary nodes and Supraclavicular nodes: 3D-CRT or IMRT at 2.7 Gy X 15 fraction (40.50 Gy). Patients will complete treatment in three weeks (15 fractions). All patients will be followed at 3 months after the completion of treatment then yearly for the next 5 years.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Radiation	(Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.

Timeline

• Start date: 2016-12-19
• Primary completion: 2023-05-19
• Completion: 2026-12-31
• First posted: 2016-09-28
• Last updated: 2026-04-17
• Results posted: 2024-06-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study