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NCT Number: NCT04175210

Prospective Randomized Study of Accelerated Radiation Therapy (PRART)

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Brooklyn Methodist Hospital - NewYork Presbyterian, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiation therapy - 3 weeks

Radiation

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 therapy - 2 weeks

Radiation

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 outcomes

  1. 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

    Time frame: up to 1-month post-radiation treatment

    Proportion 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 outcomes

  1. 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

    Time frame: 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.

  2. 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

    Time frame: 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.

  3. 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

    Time frame: 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".

  4. 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

    Time frame: 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."

  5. 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

    Time frame: 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".

  6. 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

    Time frame: 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."

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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)

Acronym: PRART

Important dates

Study start
2019
Primary completion
2025
Study completion
2030
First posted
Nov 22, 2019
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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