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Trial record 1 of 1 for:    1602017017
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Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations (ART)

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ClinicalTrials.gov Identifier: NCT02917421
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE September 19, 2016
First Posted Date  ICMJE September 28, 2016
Last Update Posted Date June 9, 2020
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
Acute toxicity will be measured by evaluating the proportion of patients who experience grade II-III dermatitis within 60 days of radiation therapy. [ Time Frame: 60 days from start of radiation therapy. ]
feasibility of accelerated radiotherapy in the post-operative setting of breast cancer patients treated by neo-adjuvant chemotherapy and surgery will be measured, by evaluating the proportion of patients who experience grade II-III dermatitis within 60 days of the end of treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
  • Quality of life of patients at various time points. [ Time Frame: Baseline and 5 years ]
  • late radiation toxicity in treated patients [ Time Frame: 5 years ]
    incidence of late radiation toxicity (brachial plexopathy, fibrosis and telangiectasia) will be evaluated and genetic determinants of breast fibrosis will be identified.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 27, 2016)
  • overall survival will be measured [ Time Frame: up to 10 years ]
  • molecular signatures that predict fibrosis will be prospectively measured from blood samples. [ Time Frame: 10 years ]
    The purpose of this portion of the study will be to collect blood from each subject accrued to the study and willing to donate a specimen of blood for research, to study the TGF-β1 polymorphisms that have been reported to be correlated with the development of fibrosis following radiotherapy for treatment of breast cancer.
  • local control rates will be measured. [ Time Frame: up to 10 years ]
  • Distant recurrences will be measured. [ Time Frame: up to 10 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations
Official Title  ICMJE Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations After Neo-adjuvant Chemotherapy and Surgery : A Feasibility Study.
Brief Summary This protocol is for patients with newly diagnosed breast cancer with an indication for post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.
Detailed Description

Protocol has two cohorts. Cohort 1 will receive radiation to breast and chest wall. Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy x 15 fractions (40.50 Gy) with a concomitant boost of 0.50 (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.

Cohort 2 patients will receive radiation to breast, chest wall and LevelII/SCV nodes.

In addition to receiving radiation to the original tumor bed, patients will also receive radiation to Level III axillary nodes and Supraclavicular nodes: 3D-CRT or IMRT at 2.7 Gy X 15 fraction (40.50 Gy).

Patients will complete treatment in three weeks (15 fractions). All patients will be followed at 3 months after the completion of treatment then yearly for the next 5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Radiation: Radiation
(Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
Study Arms  ICMJE
  • Experimental: Cohort 1

    (Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.

    Radiation therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.

    Intervention: Radiation: Radiation
  • Experimental: Cohort 2

    In addition to receiving radiation to the original tumor bed, patients will also receive radiation to Level III axillary nodes and Supraclavicular nodes: 3D-CRT or IMRT at 2.7 Gy X 15 fraction (40.50 Gy)

    Radiation Therapy : Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.

    Intervention: Radiation: Radiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2016)
74
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2024
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pre- or post-menopausal women with Stage I-III breast cancer
  • Status post neoadjuvant systemic therapy
  • Status post-chemotherapy breast surgery
  • Original biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
  • Status post segmental mastectomy or mastectomy, with either negative sentinel node biopsy and/or axillary node dissection (at least 6 nodes removed).
  • Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document

Exclusion Criteria:

  • Previous radiation therapy to the ipsilateral breast and/or nodal area
  • Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy
  • Pregnant or lactating women
  • Concurrent chemotherapy, with the exception of anti HER2neu therapies
  • Inadequate axillary dissection in a setting of positive sentinel node
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sharanya Chandrasekhar, M.S. 212-746-7277 shc2043@med.cornell.edu
Contact: Pragya Yadav, Ph.D. 212-746-2546 pry2003@med.cornell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02917421
Other Study ID Numbers  ICMJE 1602017017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Silvia Formenti, M.D. Weill Cornell Medicine - New York Presbyterian Hospital
PRS Account Weill Medical College of Cornell University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP