Prospective Randomized Study of Accelerated Radiation Therapy (PRART)

Study Overview
=================
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).

Official 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)

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Radiation: Radiation therapy - 3 weeks
* Radiation: Radiation therapy - 2 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractions<br>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 - 3 weeks<br>* 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<br>|
| Experimental: ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractions<br>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. | Radiation: Radiation therapy - 2 weeks<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events receiving radiation therapy between the two arms Arm 1 (15 fractions) and Arm 2 (10 fractions). | 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. | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who demonstrate local control at 5 year follow up | assess and compare local control at 5 years between the two arms. | 5 years |