NCT01000662

Brief Summary

All patients (with Stages 0-II breast cancer) will receive an accelerated three week regimen of prone whole breast radiotherapy. The study intends to test the hypothesis that a weekly boost to the tumor bed, delivered on Friday, before the weekend break, is as well tolerated as the daily boost during accelerated prone radiotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
412

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
Completed

Started Mar 2009

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2009

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

May 29, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2017

Completed
Last Updated

August 6, 2020

Status Verified

July 1, 2020

Enrollment Period

3.3 years

First QC Date

October 9, 2009

Results QC Date

May 12, 2015

Last Update Submit

July 23, 2020

Conditions

Breast Cancer

Keywords

whole breast radiotherapytumor bed boost

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)

    Number of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects

    Day 60

Secondary Outcomes (12)

  • Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at Baseline

    Baseline

  • Score on "SF-36 v2 Vitality" Scale

    Baseline

  • Average Score on Brief Pain Inventory (BPI) Scale

    Baseline

  • Average Score on Radiation Therapy Oncology Group (RTOG) Breast Quality of Life Scale

    Baseline

  • Average Score on Breast Cancer Treatment Outcomes Scale (BCTOS) at the End of Treatment

    At the end of Treatment, an average of 3 weeks

  • +7 more secondary outcomes

Study Arms (2)

ARM 1 daily boost

ACTIVE COMPARATOR

Radiation Therapy

Radiation: Daily Radiation Therapy

ARM 2 weekly boost

ACTIVE COMPARATOR

Radiation Therapy

Radiation: Weekly Radiation Therapy

Interventions

Daily Radiation TherapyRADIATION

15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.

ARM 1 daily boost
Weekly Radiation TherapyRADIATION

15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.

ARM 2 weekly boost

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pre or post-menopausal women with stage 0,I, and II breast cancer
  • 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 \<5mm 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bellevue Hospital Center

New York, New York, 10016, United States

Location

NYU Clinical Cancer Center

New York, New York, 10016, United States

Location

Tisch Hospital

New York, New York, 10016, United States

Location

Related Publications (3)

  • Cooper BT, Formenti-Ujlaki GF, Li X, Shin SM, Fenton-Kerimian M, Guth A, Roses DF, Hitchen CJ, Rosenstein BS, Dewyngaert JK, Goldberg JD, Formenti SC. Prospective Randomized Trial of Prone Accelerated Intensity Modulated Breast Radiation Therapy With a Daily Versus Weekly Boost to the Tumor Bed. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):571-8. doi: 10.1016/j.ijrobp.2015.12.373. Epub 2015 Dec 29.

    PMID: 27131077RESULT

  • Garsa AA, Ferraro DJ, DeWees TA, Deshields TL, Margenthaler JA, Cyr AE, Naughton M, Aft R, Gillanders WE, Eberlein T, Matesa MA, Ochoa LL, Zoberi I. A prospective longitudinal clinical trial evaluating quality of life after breast-conserving surgery and high-dose-rate interstitial brachytherapy for early-stage breast cancer. Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):1043-50. doi: 10.1016/j.ijrobp.2013.09.009. Epub 2013 Oct 22.

    PMID: 24161428RESULT

  • Finkel MA, Cooper BT, Li X, Fenton-Kerimian M, Goldberg JD, Formenti SC. Quality of Life in Women Undergoing Breast Irradiation in a Randomized, Controlled Clinical Trial Evaluating Different Tumor Bed Boost Fractionations. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):579-89. doi: 10.1016/j.ijrobp.2016.02.004. Epub 2016 Feb 6.

    PMID: 27045811DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. Silvia Formenti, Chairman, Department of Radiation Oncology
Organization
NYU Langone Medical Center
silvia.formenti@nyumc.org
(212) 731-5039

Study Officials

  • Carmen Perez, MD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2009

First Posted

October 23, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2012

Study Completion

June 14, 2017

Last Updated

August 6, 2020

Results First Posted

May 29, 2015

Record last verified: 2020-07

Locations

US(3)