Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    1602017017
Previous Study | Return to List | Next Study

Accelerated Radiation Therapy (ART) to the Breast and Nodal Stations (ART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02917421
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Radiation Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accelerated Radiation Therapy (ART) To The Breast And Nodal Stations After Neo-Adjuvant Systemic Therapy And Surgery: A Feasibility Study
Study Start Date : August 2016
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.

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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Quality of life of patients at various time points. [ Time Frame: Baseline and 5 years ]
  2. 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.

  3. Proportion of patients with grades 2 or higher toxicity [ Time Frame: 5 years ]
    Proportion of patients with grades 2 or higher toxicity


Other Outcome Measures:
  1. overall survival will be measured [ Time Frame: up to 10 years ]
  2. 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.

  3. local control rates will be measured. [ Time Frame: up to 10 years ]
  4. Distant recurrences will be measured. [ Time Frame: up to 10 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

The study will also include patients who because of COVID had undergone up to 3 months neoadjuvant hormonal therapy before surgery for clinical T1/T2 BC.

Inclusion Criteria:

  • Age older than 18
  • 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 (patients with focally positive margin are not excluded).
  • 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
  • Patients with more than 5 nodes involved at axillary dissection will be excluded from this study since they will be eligible to receive radiotherapy to level I and II axilla.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917421


Contacts
Layout table for location contacts
Contact: Sharanya Chandrasekhar, M.S. 646-962-3110 shc2043@med.cornell.edu
Contact: Pragya Yadav, Ph.D. 646-962-2199 pry2003@med.cornell.edu

Locations
Layout table for location information
United States, New York
New York Presbyterian Hospital - Queens Recruiting
New York, New York, United States, 10065
Contact: Sarah Stankiewich    718-661-7246    sas9306@nyp.org   
Contact: Sharanya Chandrasekhar    6469623110    shc2043@med.cornell.edu   
Principal Investigator: Akkamma Ravi, M.D.         
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Silvia Formenti, M.D    646-962-3110    formenti@med.cornell.edu   
Contact: Sharanya Chandrasekhar, M.S.    646-962-3110    shc2043@med.cornell.edu   
Brooklyn Methodist Hospital - NewYork Presbyterian Recruiting
New York, New York, United States, 11215
Contact: Izael Nino, M.S.    929-470-9426    izn4001@med.cornell.edu   
Contact: Pragya Yadav, Ph.D.    6469622199    pry2003@med.cornell.edu   
Principal Investigator: Hani Ashamalla, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Layout table for investigator information
Principal Investigator: Silvia Formenti, M.D. Weill Cornell Medicine - New York Presbyterian Hospital
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02917421    
Other Study ID Numbers: 1602017017
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes