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Hypofractionated Versus Conventional Fractionation Radiotherapy

Primary Purpose

Breast Cancer, Radiation Toxicity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional radiotherapy
Hypofractionated radiotherapy
Sponsored by
Hospital da Baleia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, radiotherapy, hypofractionated therapy, nodal irradiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female;
  • Older than 18;
  • Breast cancer stage T1 - T3;
  • At least 1 lymph node positive;
  • Treated with mastectomy or conservative surgery;
  • Negative surgical margins;
  • No distant metastasis;
  • No supraclavicular or internal mammary nodes metastases;
  • Adjuvant systemic therapy with chemotherapy, endocrine therapy or anti-HER2 (Human - - Epidermal Growth Factor Receptor 2) treatment is accepted;
  • Signed informed consent.

Exclusion Criteria:

  • Positive surgical margins;
  • Concomitant chemotherapy;
  • Supraclavicular or internal mammary nodes metastases;
  • Distant metastasis;
  • Previous thoracic radiotherapy;
  • Bilateral breast cancer;
  • Patients with collagen diseases;
  • Unable or unwilling to sign inform consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Conventional radiotherapy

    Hypofractionated radiotherapy

    Arm Description

    50 Gy in 25 fractions to chest wall or whole breast and regional lymph regions (supraclavicular fossa with or without axilla), followed by tumor bed boost of 10 Gy in 5 fractions in case of breast conserving surgery. Total time: 5-6 weeks.

    40 Gy in 15 fractions (2.67 Gy each) to chest wall or whole breast and regional lymph regions (supraclavicular fossa with or without axilla). Patients undergoing breast conserving surgery will receive concomitant boost with total dose of 48 Gy in 15 fractions (3.20 Gy each) to tumor bed. Total time: 3 weeks.

    Outcomes

    Primary Outcome Measures

    CTCAE Toxicity Assessement - Acute Toxicity
    Change in acute toxicity will be assessed according to criteria of CTCAE version 4.03.

    Secondary Outcome Measures

    Quality of Life - EORTC QLQ-C30 (version 3)
    Patients' quality of life will be assessed using self-administered questionnaire EORTC-QLQ-C30 (version 3).
    Quality of Life - EORTC breast cancer module (BR23)
    Patients' quality of life will be assessed using self-administered questionnaire EORTC breast cancer module (BR23).

    Full Information

    First Posted
    August 8, 2016
    Last Updated
    July 10, 2019
    Sponsor
    Hospital da Baleia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04015531
    Brief Title
    Hypofractionated Versus Conventional Fractionation Radiotherapy
    Official Title
    Hypofractionated Versus Conventional Fractionation Radiation After Conservative Surgery or Mastectomy With Irradiation of Lymph Node Drainage: a Phase II Randomized Clinical Trial for the Evaluation of Acute Toxicity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2019 (Anticipated)
    Primary Completion Date
    May 2020 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital da Baleia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study was designed to evaluate the acute toxicity and quality of life of hypofractionated radiation versus conventional when regional node irradiation is indicated after breast-conserving surgery or mastectomy.
    Detailed Description
    Investigators hypothesize that hypofractionated radiotherapy is equal effective and safe as conventional radiotherapy in breast cancer patients undergoing regional nodal irradiation. Eligible breast cancer patients are randomized 1:1 into the following two groups: Hypofractionated therapy: 40 Gy in 15 fractions of 2.67 Gy in breast or chest wall and nodal drainage with Concurrent boost 48.0 Gy / 3.2 Gy daily in tumor bed, in case of conservative surgery; Standard fractionation: 50 Gy in 25 fractions in breast or chest wall and nodal drainage with sequential tumor bed boost with 10 Gy in 5 fractions in tumor bed in case of conservative surgery. Patients will be followed for 6 months after radiotherapy to evaluate acute toxicity and quality of life.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Radiation Toxicity
    Keywords
    breast cancer, radiotherapy, hypofractionated therapy, nodal irradiation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Radiation toxicity will be analysed by a blind second investigator.
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional radiotherapy
    Arm Type
    Active Comparator
    Arm Description
    50 Gy in 25 fractions to chest wall or whole breast and regional lymph regions (supraclavicular fossa with or without axilla), followed by tumor bed boost of 10 Gy in 5 fractions in case of breast conserving surgery. Total time: 5-6 weeks.
    Arm Title
    Hypofractionated radiotherapy
    Arm Type
    Experimental
    Arm Description
    40 Gy in 15 fractions (2.67 Gy each) to chest wall or whole breast and regional lymph regions (supraclavicular fossa with or without axilla). Patients undergoing breast conserving surgery will receive concomitant boost with total dose of 48 Gy in 15 fractions (3.20 Gy each) to tumor bed. Total time: 3 weeks.
    Intervention Type
    Radiation
    Intervention Name(s)
    Conventional radiotherapy
    Other Intervention Name(s)
    Standard fractionation
    Intervention Description
    50 Gy / 25 fractions / 5-6 weeks / Sequential boost of 10 Gy in 5 fractions, in case of conservative surgery.
    Intervention Type
    Radiation
    Intervention Name(s)
    Hypofractionated radiotherapy
    Other Intervention Name(s)
    Hypofractionated therapy
    Intervention Description
    40 Gy / 15 fractions / 3 weeks / Concomitant boost with total dose of 48 Gy in 15 fractions, in case of conservative surgery.
    Primary Outcome Measure Information:
    Title
    CTCAE Toxicity Assessement - Acute Toxicity
    Description
    Change in acute toxicity will be assessed according to criteria of CTCAE version 4.03.
    Time Frame
    Before treatment, every week of treatment (week 1 to 3 or 1 to 5-6, according to the treatment arm), at the end of treatment (week 3 or week 5-6, according to the treatment arm), 4, 8 and 24 weeks after the last fraction received.
    Secondary Outcome Measure Information:
    Title
    Quality of Life - EORTC QLQ-C30 (version 3)
    Description
    Patients' quality of life will be assessed using self-administered questionnaire EORTC-QLQ-C30 (version 3).
    Time Frame
    Before treatment, at the end of treatment (week 3 or week 5-6, according to the treatment arm),1 and 6 months after last fraction received.
    Title
    Quality of Life - EORTC breast cancer module (BR23)
    Description
    Patients' quality of life will be assessed using self-administered questionnaire EORTC breast cancer module (BR23).
    Time Frame
    Before treatment, at the end of treatment (week 3 or week 5-6, according to the treatment arm),1 and 6 months after last fraction received.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female; Older than 18; Breast cancer stage T1 - T3; At least 1 lymph node positive; Treated with mastectomy or conservative surgery; Negative surgical margins; No distant metastasis; No supraclavicular or internal mammary nodes metastases; Adjuvant systemic therapy with chemotherapy, endocrine therapy or anti-HER2 (Human - - Epidermal Growth Factor Receptor 2) treatment is accepted; Signed informed consent. Exclusion Criteria: Positive surgical margins; Concomitant chemotherapy; Supraclavicular or internal mammary nodes metastases; Distant metastasis; Previous thoracic radiotherapy; Bilateral breast cancer; Patients with collagen diseases; Unable or unwilling to sign inform consent.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gabriel Oliveira B Gil, MD
    Phone
    55 31 984463767
    Email
    gabrielbgil@yahoo.com.br
    First Name & Middle Initial & Last Name or Official Title & Degree
    Darly GS Delfino, MSc
    Phone
    55 31 971735501
    Email
    darlygsoares@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gabriel Oliveira B Gil, MD
    Organizational Affiliation
    Baleia Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Use of a controlled access approach, with a transparent system to review requests and provide secure data access; assurance that patient privacy and confidentiality can be maintained;
    IPD Sharing Time Frame
    From 2020 onwards
    IPD Sharing Access Criteria
    Principal investigator's e-mail
    Citations:
    PubMed Identifier
    30711522
    Citation
    Wang SL, Fang H, Song YW, Wang WH, Hu C, Liu YP, Jin J, Liu XF, Yu ZH, Ren H, Li N, Lu NN, Tang Y, Tang Y, Qi SN, Sun GY, Peng R, Li S, Chen B, Yang Y, Li YX. Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):352-360. doi: 10.1016/S1470-2045(18)30813-1. Epub 2019 Jan 30.
    Results Reference
    background
    PubMed Identifier
    24656685
    Citation
    EBCTCG (Early Breast Cancer Trialists' Collaborative Group); McGale P, Taylor C, Correa C, Cutter D, Duane F, Ewertz M, Gray R, Mannu G, Peto R, Whelan T, Wang Y, Wang Z, Darby S. Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials. Lancet. 2014 Jun 21;383(9935):2127-35. doi: 10.1016/S0140-6736(14)60488-8. Epub 2014 Mar 19. Erratum In: Lancet. 2014 Nov 22;384(9957):1848.
    Results Reference
    background
    PubMed Identifier
    26021276
    Citation
    Duxbury PJ, Gandhi A, Kirwan CC, Jain Y, Harvey JR. Current attitudes to breast reconstruction surgery for women at risk of post-mastectomy radiotherapy: A survey of UK breast surgeons. Breast. 2015 Aug;24(4):502-12. doi: 10.1016/j.breast.2015.05.002. Epub 2015 May 26.
    Results Reference
    background
    PubMed Identifier
    18356109
    Citation
    START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol. 2008 Apr;9(4):331-41. doi: 10.1016/S1470-2045(08)70077-9. Epub 2008 Mar 19.
    Results Reference
    background
    PubMed Identifier
    26247543
    Citation
    Shaitelman SF, Schlembach PJ, Arzu I, Ballo M, Bloom ES, Buchholz D, Chronowski GM, Dvorak T, Grade E, Hoffman KE, Kelly P, Ludwig M, Perkins GH, Reed V, Shah S, Stauder MC, Strom EA, Tereffe W, Woodward WA, Ensor J, Baumann D, Thompson AM, Amaya D, Davis T, Guerra W, Hamblin L, Hortobagyi G, Hunt KK, Buchholz TA, Smith BD. Acute and Short-term Toxic Effects of Conventionally Fractionated vs Hypofractionated Whole-Breast Irradiation: A Randomized Clinical Trial. JAMA Oncol. 2015 Oct;1(7):931-41. doi: 10.1001/jamaoncol.2015.2666.
    Results Reference
    background
    PubMed Identifier
    25494006
    Citation
    Bekelman JE, Sylwestrzak G, Barron J, Liu J, Epstein AJ, Freedman G, Malin J, Emanuel EJ. Uptake and costs of hypofractionated vs conventional whole breast irradiation after breast conserving surgery in the United States, 2008-2013. JAMA. 2014 Dec 17;312(23):2542-50. doi: 10.1001/jama.2014.16616.
    Results Reference
    background
    PubMed Identifier
    25539365
    Citation
    Jagsi R, Falchook AD, Hendrix LH, Curry H, Chen RC. Adoption of hypofractionated radiation therapy for breast cancer after publication of randomized trials. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1001-9. doi: 10.1016/j.ijrobp.2014.09.032.
    Results Reference
    background

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