Prospective Randomized Study of Accelerated Radiation Therapy (PRART)

Phase 3

Recruiting

• Conditions: Breast Cancer
• Interventions: Radiation: Radiation therapy - 3 weeks; Radiation: Radiation therapy - 2 weeks

• Registration Number: NCT04175210
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-20
• Study Start: 2019-11-21
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26
• Primary Completion: 2027-02-28
• Study Completion: 2030-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Women status post segmental mastectomy
• If unilateral, pT1-2 breast cancer excised with negative margins
• If bilateral, pT1-2 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
• Clinically N0 or pN0 or sentinel node negative
• Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).

Exclusion Criteria

• Previous radiation therapy to the ipsilateral breast.
• 90 days from last surgery, unless s/p adjuvant chemotherapy
• 60 days from last chemotherapy
• Male breast cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractions	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
ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractions	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.

Primary Outcome Measures

Name	Time	Method
Proportions of patients with adverse cosmetic outcomes	up to 2 years	rate of grade 3 or higher changes in breast cosmesis on the 10 fraction arm compared to the rate on the 15 fraction arm will be measured.

Secondary Outcome Measures

Name	Time	Method
Number of participants who demonstrate local control at 5 year follow up	5 years	assess and compare local control at 5 years between the two arms.

Trial Locations

Locations (3)

New York Presbyterian Hospital at Lower Manhattan Cancer Center; 🇺🇸 New York, New York, United States

New York Presbyterian Hospital - Queens; 🇺🇸 New York, New York, United States

Brooklyn Methodist Hospital - NewYork Presbyterian; 🇺🇸 New York, New York, United States