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Hypofractionated Radiation Therapy in Patients With Breast Cancer (HRBC)

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ClinicalTrials.gov Identifier: NCT04075058
Recruitment Status : Enrolling by invitation
First Posted : August 30, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Budhi Singh Yadav, Postgraduate Institute of Medical Education and Research

Brief Summary:
The investigators at PGIMER have been practicing hypofractionation radiotherapy with a dose of 35Gy/15#/3wks to the chest wall in post mastectomy and 40Gy/16#/3wks in breast conservation in breast cancer patients for the last 4 decades. It is also a routine practice in UK and few centers in Canada. Hypofractionation reduces treatment time to half while maintaining cosmesis and gives control rates equal to conventional fractionation. As breast cancer is a leading cancer in females and radiation therapy is an important part of its local management, hypofractionation help the radiation centers worldwide to meet the growing need for radiation in breast cancer, particularly in developing countries where resources are limited. It also reduces the financial burden on the patient and family. In this study the investigators want to reduce the treatment duration from 3 weeks to 2 weeks. The study will include 1000 patients, 500 in each arm, with breast cancer post mastectomy or after breast conservative surgery to be treated with a radiotherapy dose of 34Gy in 10 fractions over 2 weeks in the study arm and 35Gy in 15 fractions over 3 weeks in the control arm. The primary endpoint of the study will be ipsilateral local tumour control. Secondary endpoints will be early and late adverse effects in normal tissues, quality of life, contralateral primary tumours, regional and distant metastases and survival.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Hypofractionated Radiation therapy Phase 3

Detailed Description:
Patients to be included in this study will be pre-operatively staged according to American Joint Committee on Cancer (AJCC) 7th edition, International Union against cancer ( which uses TNM staging ) as stage I-III of breast carcinoma. Total 500 patients of histologically proven post lumpectomy/mastectomy cases of carcinoma breast suitable for radiotherapy will be enrolled in this study. Patients would be evaluated at the Department of Radiotherapy PGIMER, Chandigarh by doing a thorough clinical examination followed by routine investigations which will include hemogram, liver function tests, kidney function tests, chest X-ray. Patients will be treated by standard rectangular tangential fields.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study Comparing Two Adjuvant Hypofractionated Radiation Schedules in Patients With Breast Cancer
Study Start Date : June 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Study
Patients with breast cancer post mastectomy or after breast conservative surgery to be treated with a hypofractionated radiotherapy dose of 34Gy in 10 fractions over 2 weeks.
Radiation: Hypofractionated Radiation therapy
Active Comparator: Control
Patients with breast cancer post mastectomy or after breast conservative surgery to be treated with a hypofractionated radiotherapy dose of 35Gy in 15 fractions over 3 weeks
Radiation: Hypofractionated Radiation therapy



Primary Outcome Measures :
  1. Local Recurrence [ Time Frame: 5 years ]
    Any recurrence with in the irradiated area from completion of radiation


Secondary Outcome Measures :
  1. Acute skin toxicity [ Time Frame: After 1 month of completion of radiation ]
    Acute toxicity will be assessed using a RTOG grading system. Assessment will be carried out weekly during radiotherapy and for 4 weeks after treatment.

  2. Cosmetic assessment [ Time Frame: Baseline, 1 year, 3 years, 5 years ]
    done using Harvard/National Surgical Adjuvant Bowel and Breast Project(NSABP)/Radiation Therapy Oncology Group(RTOG) breast cosmesis grading scale. Grading will be done as Excellent- no or minimal difference between two breasts,Good- slight difference between two breasts,Good- slight and Fair minimal difference between two breasts, Fair- obvious difference between two breasts Poor- marked difference between two breasts. Excellent/good and fair/poor will be considered better and worse outcomes, respectively.

  3. Quality of life [ Time Frame: 3 year, 5 year ]
    EORTC QLQ -30 The QLQ-C30 is composed of both multi-item scales and single-item measures, as well as five functional scales, three symptom scales, a global health status/QoL scale, and six single items.The scores must be averaged and linearly transformed to obtain a range of scores from 0 to 100, with a higher score representing a greater response level. Thus, a high score for a functional scale represents a healthy level of functioning and a high score for the global health status represents a high QoL, but a high score for the symptom scale represents a high level of symptomatology.

  4. Quality of life [ Time Frame: 3 year, 5 year ]
    EORTC QLQ-BR 23 It contains 23 items rated on a four-point scale ranging from 1 (not at all) to 4 (very much). The items assess the side effects of therapy, arm symptoms, breast symptoms, body image, and sexual function. Additionally, there are single items assessing sexual enjoyment, anxiety caused by hair loss, and future outlook. The scores range between 0-100 points. For scales evaluating function, a higher score represents a higher level of functioning. For scales evaluating symptoms, a higher score indicates more severe symptoms.

  5. Disease free survival [ Time Frame: 5 years, 10 years ]
    Time interval free from locoregional recurrence and metastasis

  6. Overall survival [ Time Frame: 5 years, 10 years ]
    From the date of diagnosis to death

  7. Arm edema [ Time Frame: 3 years, 5 years, 10 years ]
    Will be graded by measuring arm circumference 10cm above and below the medial epicondyle of humerus. Treated side will be compared with the untreated opposite side as a reference. It will be classified as none, mild, moderate and marked if there was no difference, 0.5-2cm, 2.1-3cm and >3cm difference, respectively in the circumference of the affected and normal arm.

  8. Late effects- pain, shoulder stiffness [ Time Frame: 3 years, 5 years, 10 years ]
    A four point scale(none, a little, quite a bit, very much ) will be used to asess all late effects according to the RTOG LENT SOMA scale(Cox et al, 1995).

  9. Late effects- Brachial plexopathy [ Time Frame: 3 years, 5 years, 10 years ]
    If the patient had symptoms of pain in the arm, paresthesia, numbness, weakness, or other sensory symptoms then injury to the brachial plexus will be suspected and reported as brachial plexopathy.

  10. Late effects- Lung, cardiac [ Time Frame: 5 years, 10 years ]
    Late lung and cardiac toxicity asess all late effects according to the RTOG LENT SOMA scale (Cox et al, 1995).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Invasive carcinoma of the breast
  • Breast conservation surgery or mastectomy
  • Axillary staging &/or dissection
  • Complete microscopic excision of primary tumour
  • pT1-3 pN0-2 M0 disease
  • Written informed consent
  • Able to comply with follow up

Exclusion Criteria:

  • Past history of malignancy except (i) basal cell skin cancer and CIN cervix uteri or (ii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free
  • Contralateral breast cancer, including DCIS, irrespective of date of diagnosis
  • Breast reconstruction using implants
  • Concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed)

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): NCT04075058


Locations
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India
Dr Budhi Singh Yadav
Chandigarh, N/A = Not Applicable, India, 91 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Principal Investigator: Budhi S Yadav, MD PGIMER, Chandigarh, India
Publications of Results:
Other Publications:
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Responsible Party: Dr Budhi Singh Yadav, Additional Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT04075058    
Other Study ID Numbers: HRBC
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Keywords provided by Dr Budhi Singh Yadav, Postgraduate Institute of Medical Education and Research:
Breast cancer
hypofractionated radiotherapy
Hypofractionated radiation
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases