Prospective Randomized Study of Accelerated Radiation Therapy (PRART)

Weill Cornell Medicine (WCM)

Status and phase: Active, not recruiting; Phase 3

Conditions: Breast Cancer

Treatments: Radiation: Radiation therapy - 3 weeks; Radiation: Radiation therapy - 2 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT04175210

19-07020533

Details and patient eligibility

About

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).

Enrollment: 400 estimated patients

Sex: Female

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

ARM 1-4050cGY and boost to tumor bed of 4800cGY in 15fractions

Experimental group

Description:

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

Treatment:

Radiation: Radiation therapy - 3 weeks

ARM 2 - 3200cGY and boost to tumor bed of 4200cGY -10fractions

Experimental group

Description:

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.

Treatment:

Radiation: Radiation therapy - 2 weeks