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出境医 / 临床实验 / Hypofractionated Versus Conventional Fractionation Radiotherapy

Hypofractionated Versus Conventional Fractionation Radiotherapy

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.

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.

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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).


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Contacts
Layout table for location contacts
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
Layout table for investigator information
Principal Investigator: Gabriel Oliveira B Gil, MD Baleia Hospital
Tracking Information
First Submitted Date  ICMJE August 8, 2016
First Posted Date  ICMJE July 11, 2019
Last Update Posted Date July 11, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypofractionated Versus Conventional Fractionation Radiotherapy
Official Title  ICMJE 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
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:

  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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Breast Cancer
  • Radiation Toxicity
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.

    Intervention: Radiation: Conventional radiotherapy
  • 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.

    Intervention: Radiation: Hypofractionated radiotherapy
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2019) 		80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gabriel Oliveira B Gil, MD 55 31 984463767 gabrielbgil@yahoo.com.br
Contact: Darly GS Delfino, MSc 55 31 971735501 darlygsoares@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04015531
Other Study ID Numbers  ICMJE RT 1901
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: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: From 2020 onwards
Access Criteria: Principal investigator's e-mail
Responsible Party Hospital da Baleia
Study Sponsor  ICMJE Hospital da Baleia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gabriel Oliveira B Gil, MD Baleia Hospital
PRS Account Hospital da Baleia
Verification Date July 2019

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

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