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Hypofractionated Versus Conventional Fractionation Radiotherapy

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ClinicalTrials.gov Identifier: NCT04015531
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital da Baleia

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation Toxicity Radiation: Conventional radiotherapy Radiation: Hypofractionated radiotherapy Not Applicable

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:

  1. 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;
  2. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Radiation toxicity will be analysed by a blind second investigator.
Primary Purpose: Treatment
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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conventional radiotherapy

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.

Radiation: Conventional radiotherapy
50 Gy / 25 fractions / 5-6 weeks / Sequential boost of 10 Gy in 5 fractions, in case of conservative surgery.
Other Name: Standard fractionation

Experimental: Hypofractionated radiotherapy

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.

Radiation: Hypofractionated radiotherapy
40 Gy / 15 fractions / 3 weeks / Concomitant boost with total dose of 48 Gy in 15 fractions, in case of conservative surgery.
Other Name: Hypofractionated therapy




Primary Outcome Measures :
  1. CTCAE Toxicity Assessement - Acute Toxicity [ 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. ]
    Change in acute toxicity will be assessed according to criteria of CTCAE version 4.03.


Secondary Outcome Measures :
  1. Quality of Life - 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. ]
    Patients' quality of life will be assessed using self-administered questionnaire EORTC-QLQ-C30 (version 3).

  2. Quality of Life - 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. ]
    Patients' quality of life will be assessed using self-administered questionnaire EORTC breast cancer module (BR23).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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): NCT04015531


Contacts
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Contact: Gabriel Oliveira B Gil, MD 55 31 984463767 gabrielbgil@yahoo.com.br
Contact: Darly GS Delfino, MSc 55 31 971735501 darlygsoares@gmail.com

Sponsors and Collaborators
Hospital da Baleia
Investigators
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Principal Investigator: Gabriel Oliveira B Gil, MD Baleia Hospital

Publications:

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Responsible Party: Hospital da Baleia
ClinicalTrials.gov Identifier: NCT04015531     History of Changes
Other Study ID Numbers: RT 1901
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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;
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: From 2020 onwards
Access Criteria: Principal investigator's e-mail

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital da Baleia:
breast cancer
radiotherapy
hypofractionated therapy
nodal irradiation