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Trial to Compare Radiation Fibrosis With Five Versus Three Fractions

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: NCT02755896
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
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Brief Summary:
Post meno-pausal women with T1 Breast cancers will be randomized to receive either 600 centiGray (cGy) X 5 over five consecutive days (arm 1) versus 800 cGy X 3 fractions given every other day (arm 2). Patients will complete treatment in one week. All patients will be followed a month after the completion of treatment then q6 months for the first year, then yearly for the next 10 years.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Breast Stage I Radiation: Arm 1 600 cGY x 5 fractions Radiation: Arm 2 800 cGY x 3 fractions Phase 2

Detailed Description:

Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation. No type I or II evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and Radiation therapy Oncology Group (RTOG) (NSABP B-39 and RTOG 0413) has completed accruing patients, comparing whole breast radiotherapy to PBI, either by brachytherapy or external beam techniques (EB): results of this trial are pending. Until results of this or similar trials are available, PBI remains a research domain, and it should be offered to patients only in the context of a clinical experimental protocol. Despite the fact that less extensive experience than that of brachytherapy is available, PBI delivery through an external-beam has many advantages. First of all, it is likely to be more acceptable to the patient since it is non-invasive and it does not require a surgical procedure or anesthesia. Moreover, since it is delivered after surgery, the pathological analysis of the segmental mastectomy specimen is available to inform the selection of the best candidates. In addition, EB-PBI is likely to become more widely reproducible, since it does not rely on the experience and skills of the radiation oncologist performing the brachytherapy implant. Besides, once the technique is established, it can be widely applied at any facility provided with a linear accelerator, without the risk presented by some brachytherapy approaches that cannot be completed because of the unfavorable interplay of patient's anatomy with the technical limitations of the applicator. Finally, in terms of health care economics, an external beam approach spares the costs of an extra surgical procedure and several days as inpatient (in the case of Low dose Rate (LDR) brachytherapy).

A prone approach for partial breast radiation has been tested at NYU in a clinical trial sponsored by an IDEA grant of the Department of Defense (NYU 00-23). Results of the first 47 patient accrued originally demonstrated feasibility. Eligibility to this study was limited to post-menopausal women with non-palpable, mammographically detected tumors. In addition, the protocol required patients to have first refused to undergo standard six-week radiotherapy. Five fractions of 6 Gy were delivered to the Planning Target Volume (PTV) over ten days (Monday-Wednesday-Friday, Monday-Wednesday). The dose and fractionation was based on radiobiological modeling, aimed at determining a dose to deliver in five fractions that would achieve equivalence to the tumor control estimates of 50 Gy in 25 fractions, while maintaining a risk of fibrosis at the tumor bed comparable to that of a standard regimen of 60 Gy in 30 fractions. An α/β = 4 for tumor control was used, and its validity has been recently confirmed by the results of a prospective randomized trial comparing accelerated to standard whole breast radiotherapy.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prone Partial Breast Irradiation (PBI): Prospective Randomized Controlled Non-inferiority Trial to Compare Radiation Fibrosis With Five Versus Three Fractions
Study Start Date : July 2015
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Arm 1 - 600 cGY x 5 fractions
Patients will receive 600 cGY x 5 fractions of radiation therapy over 5 consecutive days.
 Radiation: Arm 1 600 cGY x 5 fractions
Patients who are randomized to Arm 1 will receive either 600 cGY x 5 fractions over 5 consecutive days
Arm 2 - 800 cGY x 3 fractions
Patients will receive 800 cGY x 3 fractions of radiation therapy every other day for 3 days.
 Radiation: Arm 2 800 cGY x 3 fractions
Patients who are randomized to Arm 2 will receive 800 cGY x 3 fractions given every other day


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with grade 2 or 3 fibrosis between the two treatment groups will be compared. [ Time Frame: 60 months ]
    The primary analysis will be the difference in proportions of patients with grade 2 or 3 fibrosis between the two treatment groups compared using a non-inferiority z- test. The proportions of patients by grade of fibrosis will be compared in the two treatment arms using contingency table methods and chi square tests.


Secondary Outcome Measures :
  1. Recurrence rates will be documented [ Time Frame: 60 months ]
    Rates of recurrence at 1, 2, and 3 years post-randomization will be estimated with 95% confidence limits within treatment groups along with plots of Kaplan-Meier time to recurrence curves


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Post-menopausal women with status post segmental mastectomy defined as either 1) at least 2 years without menstrual period or 2) or patients older than 50 with serological evidence of post-menopausal status or 3) hysterectomized patients of any age with Follicle Stimulating Hormone (FSH) confirmation of post-menopausal status.
  2. Stage 1 (pT1) breast cancer, excised with negative margins.
  3. clinically N0 or No Regional Lymph node (pN0) or sentinel node negative

Exclusion Criteria:

  1. Previous radiation therapy to the ipsilateral breast.
  2. Presence of a proportion of Ductal Carcinoma in-situ (DCIS) in the core biopsy specimen which is compatible with extensive intraductal component (EIC).
Contacts and Locations
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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): NCT02755896


Contacts
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Contact: Sharanya Chandrasekhar, M.S. 646-962-2196 shc2043@med.cornell.edu
Contact: Vijayalakshmi Nagaraj, Ph.D. 646-962-3118 vin2009@med.cornell.edu

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: America Casillas-Lopez    323-865-0804    America.Casillas-Lopez@med.usc.edu   
Contact: Sharanya Chandrasekhar, M.S.    646-962-2196    shc2043@med.cornell.edu   
Principal Investigator: Jason Ye, M.D.         
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Silvia Formenti, M.D    212-746-7277    formenti@med.cornell.edu   
Contact: Sharanya Chandrasekhar, M.S.    212-746-7277    shc2043@med.cornell.edu   
Principal Investigator: Silvia Formenti, M.D.         
Brooklyn Methodist Hospital - NewYork Presbyterian Recruiting
New York, New York, United States, 11215
Contact: Sharanya Chandrasekhar, M.S.    646-962-2196    shc2043@med.cornell.edu   
Contact: Pragya Yadav, Ph.D.    6469622199    pry2003@med.cornell.edu   
Principal Investigator: Hani Ashamalla, M.D.         
New York Presbyterian Hospital - Queens Recruiting
New York, New York, United States, 11355
Contact: Sarah Stankiewicz, B.S.    718-661-7246    sas9306@nyp.org   
Contact: Sharanya Chandrasekhar, M.S.    646-962-2196    shc2043@med.cornell.edu   
Sub-Investigator: Akkamma Ravi, M.D.         
Principal Investigator: Silvia Formenti, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Silvia C Formenti, M.D. Weill Medical College of Cornell University
More Information
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02755896    
Other Study ID Numbers: 1505016201
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data and medical information obtained will be kept confidential to the extent permitted by law and will not be released without the patient's written permission except as described in this paragraph. In all study forms, patients will be identified only by their initials and patient number. Patient names will not be reported in any publication; only the data obtained as a result of their participation in this study will be made public.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Neoplasms
Breast Neoplasms
Radiation Pneumonitis
Neoplasms by Site
Breast Diseases
Skin Diseases
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Radiation Injuries
Wounds and Injuries