NCT04175210

Prospective Randomized Study of Accelerated Radiation Therapy (PRART)

Prospective Randomized Study of Accelerated Radiation Therapy (PRART) : A Non-Inferiority Trial to Compare Breast Cosmesis and Local Control After Concomitant Boost Breast Radiotherapy With Fifteen Fractions in Three Weeks (Arm 1, Standard) Versus Ten Fractions in Two Weeks (Arm 2, Experimental)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Female
• Age: 19 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Patients with Stage 0 ductal carcinoma in situ (Tis (DCIS), Stage T1-T2, lymph node negative(N0) breast cancers will be randomized to receive whole breast radiotherapy with a concomitant boost to the tumor bed over 15 fractions (Arm 1, standard) versus 10 fractions (Arm 2, experimental).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Radiation therapy - 3 weeks	Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions
RADIATION	Radiation therapy - 2 weeks	Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions.

Timeline

• Start date: 2019-11-21
• Primary completion: 2025-07-15
• Completion: 2030-06-30
• First posted: 2019-11-22
• Last updated: 2025-07-25

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study