Prospective Trial of Two Prone Breast Radiotherapy Techniques With Randomization to Concurrent Versus Weekly Boost

NCT01591811 | Completed Phase 3 DMC

• 1 other identifier: 12-01299
• Study Type: interventional
• Target: 433
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To test the hypothesis that when prone, patients treated with 3D-CRT breast radiotherapy and randomly assigned to either a weekly or a daily boost to the tumor bed develop acute toxicity that is not significantly worse than that of a concurrent cohort of patients treated with IMRT randomly assigned to a weekly or daily boost regimen.
2. 2.To test the hypothesis that when prone, patients treated with 3D-CRT breast radiotherapy, randomly assigned to either a weekly or a daily boost to the tumor bed develop late toxicity that is not significantly worse than that of concurrent cohort of patients treated with IMRT randomly assigned to a weekly of daily boost.
3. 3.To test hypothesis that 5 year local control rates of ≤ 5% in-breast recurrence can be achieved in each of the two randomized arms, for either technique tested.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Number of patients with acute radiation toxicity of Grade 2 or higher.

  By accruing 1000 patients randomized in strata defined by the two approaches to either weekly or daily boost, we will be able to establish the feasibility using different techniques and toxicity of prone breast radiotherapy with a weekly versus a daily boost, with IMRT and with 3DCRT non-IMRT approaches.

  Up to 90 days of radiation treatment

• Number of patients with late radiation toxicity.

  By accruing 1000 patients randomized in strata defined by the two approaches to either weekly or daily boost, we will be able to establish the feasibility using different techniques and toxicity of prone breast radiotherapy with a weekly versus a daily boost, with IMRT and with 3DCRT non-IMRT approaches.

  90 days following radiation treatment up to 5years

• Local Recurrence

  To compare local control rates, distant recurrence and overall survival for weekly versus daily boost within strata defined by 3DCRT or IMRT at 2 and 5 year follow-up.

  up to 5 years

Study Arms (2)

Arm 1 Daily Boost of Radiation Therapy

EXPERIMENTAL

Arm 1 of treatment, you will be receiving 15 daily radiation fractions of 2.7 Gy (measure of radiation dose) daily for three weeks to the entire breast with a daily concomitant boost of 0.5 Gy

Radiation: Arm 1 Daily Boost of Radiation Therapy

Arm 2 Weekly Boost of Radiation Therapy

EXPERIMENTAL

Arm 2 Weekly Boost will receive 15 daily radiation fractions of 2.7 Gy for three weeks to the entire breast with a weekly boost of 2.0 GY.

Radiation: Arm 2 Weekly Boost of Radiation Therapy

Interventions

Arm 1 Daily Boost of Radiation Therapy RADIATION

Arm 1 Daily boost. IMRT at 2.7Gy x15 fractions. Total dose 40.50Gy. Daily Boost 0.5Gy to tumor bed x 15 fractions. Tumor Bed Total=48Gy

Also known as: Radiation Therapy

Arm 1 Daily Boost of Radiation Therapy

Arm 2 Weekly Boost of Radiation Therapy RADIATION

Arm2: IMRT at 2.7Gy x 15 fractions. Total Dose=40.50 Gy. Weekly Boost 2Gy (on Friday). Tumor Bed Total 46.50Gy

Also known as: Radiotherapy

Arm 2 Weekly Boost of Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre- or post-menopausal women with Stage 0, I and II breast cancer (Post-menopausal women defined as either (a) at least 2 years without menstrual period or (b) or patients older than 50 with serological evidence of post-menopausal status or (c) hysterectomized patients of any age with FSH confirmation of post-menopausal status)
• Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
• Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (DCIS and Tumors \<5 mm in size do not require nodal assessment)
• At least 2 weeks from last chemotherapy
• Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document

You may not qualify if:

• Previous radiation therapy to the ipsilateral breast
• More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation
• Active connective tissue disorders, such as lupus or scleroderma
• Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free \> 3 years
• Pregnant or lactating women

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Cancer Institute

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Carmen Perez, M.D., Ph.D.

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: May 4, 2012
• Study Start: April 16, 2012
• Primary Completion: April 30, 2015
• Study Completion: April 30, 2015
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

US (1)