Prospective Randomized Study of Accelerated Radiation Therapy (PRART)

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04175210
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
19 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Nov 21, 2019
Status verified
May 2026
Primary completion
Jul 15, 2025
Completion
Jun 30, 2030

Study Design

Enrollment
397 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractions
    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
  • Experimental: ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractions
    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 Measure

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 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Brooklyn Methodist Hospital - NewYork PresbyterianNew YorkNew York11215-
New York Presbyterian Hospital - QueensNew YorkNew York11355-
New York Presbyterian Hospital at Lower Manhattan Cancer CenterNew YorkNew York10007-

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Brooklyn Methodist Hospital - NewYork Presbyterian· New York, NYNew York Presbyterian Hospital - Queens· New York, NYNew York Presbyterian Hospital at Lower Manhattan Cancer Center· New York, NY

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