Prospective Randomized Study of Accelerated Radiation Therapy (PRART)

Phase 3

Active, not recruiting

• Conditions: Breast Cancer

• 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: 2025-07
• Primary Completion: 2025-07-15
• Last Update Submitted: 2025-07-24
• Last Update Posted: 2025-07-25
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_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).
• Women with previous contralateral breast cancer.

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

Primary Outcome Measures

Name	Time	Method
Proportion of patients with acute toxicity grade ≥ 2 on the 10-fraction arm compared to proportion of patients with acute toxicity grade ≥ 2 on the 15-fraction arm evaluated up to 1-month post-radiation treatment	up to 1-month post-radiation treatment	Rate of grade ≥ 2 of acute toxicity defined according to the Common Terminology Criteria for Adverse Events (CTCAEs) - version 5.0, on the 10-fraction arm compared to the rate on the 15-fraction arm will be measured, up to 1-month post-radiation treatment.

Secondary Outcome Measures

Name	Time	Method
Number of subjects with fibrosis defined per grades according to LENT/SOMA fibrosis scoring system on the 10-fraction arm and on the 15-fraction arm evaluated at 2-3 years post-radiation treatment	2-3 years	Assess and compare fibrosis at 2-3 years between the two arms. At each post treatment follow-up visit, the fibrosis will be assessed by breasts palpation performed by the physician or nurse practitioner and will be measured as per LENT/SOMA fibrosis scoring system. According to this scoring system, fibrosis is categorized into three grades (Grade 1, Grade 2 and Grade 3), where Grade 1 is defined as "barely palpable, increased density" and Grade 3 is defined as "very marked density, retraction, and fixation".
Number of subjects reporting breast cosmesis according to BCTOS questionnaire on the 10-fraction arm and on the 15-fraction arm evaluated at 2-3 years post-radiation treatment	2-3 years	Assess and compare breast cosmesis at 2-3 years between the two arms. At each post treatment follow-up visit, breast cosmesis will be self-assessed by the patient using Breast Cancer Treatment Outcome Scale (BCTOS) questionnaires. According to this scale, breast cosmesis is evaluated using a four-point system (Point 1, Point 2, Point 3, and Point 4), where Point 1 is defined as "no change compared to the untreated breast" and Point 4 as "large change compared to the untreated breast."
Proportion of patients with local breast cancer control on the 10-fraction arm compared to proportion of patients with local breast cancer control on the 15-fraction arm evaluated at 2-3 years post-radiation treatment	2-3 years	Assess and compare local control at 2-3 years between the two arms. At each post treatment follow-up visit, a physical exam to detect breast clinical recurrence will be performed. Mammographic studies and/or breast MRI will be performed and reviewed on an annual basis, according to the standard care. Local control will be defined according to the findings from physical exam, mammographic studies and/or breast MRI.
Proportion of patients with local breast cancer control on the 10-fraction arm compared to proportion of patients with local breast cancer control on the 15-fraction arm evaluated at 5 years post-radiation treatment	5 years	Assess and compare local control at 5 years between the two arms. At each post treatment follow-up visit, a physical exam to detect breasts clinical disease recurrence will be performed. Mammographic studies and/or breast MRI will be performed and reviewed on an annual basis, according to the standard care. Local control will be defined according to the findings from physical exam, mammographic studies and/or breasts MRI.
Number of subjects with fibrosis defined per grades according to LENT/SOMA fibrosis scoring system on the 10-fraction arm and on the 15-fraction arm evaluated at 5 years post-radiation treatment	5 years	Assess and compare fibrosis at 5 years between the two arms. At each post treatment follow-up visit, the fibrosis will be assessed by breasts palpation performed by the physician or nurse practitioner and will be measured as per LENT/SOMA fibrosis scoring system. According to this scoring system, fibrosis is categorized into three grades (Grade 1, Grade 2 and Grade 3), where Grade 1 is defined as "barely palpable, increased density" and Grade 3 is defined as "very marked density, retraction, and fixation".
Number of subjects reporting breast cosmesis according to BCTOS questionnaire on the 10-fraction arm and on the 15-fraction arm evaluated at 5 years post-radiation treatment	5 years	Assess and compare breast cosmesis at 5 years between the two arms. At each post treatment follow-up visit, breast cosmesis will be self-assessed by the patient using Breast Cancer Treatment Outcome Scale (BCTOS) questionnaires. According to this scale, breast cosmesis is evaluated using a four-point system (Point 1, Point 2, Point 3, and Point 4), where Point 1 is defined as "no change compared to the untreated breast" and Point 4 as "large change compared to the untreated breast."

Trial Locations

Locations (3)

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

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

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