AzTrials
AzTrials

Breast CancerPhase 3HRBCNCT04075058

Hypofractionated Radiation Therapy in Patients With Breast Cancer

A Phase 3 study testing Hypofractionated Radiation therapy in people with Breast Cancer, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Breast Cancer
What is being tested?
Hypofractionated Radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,070 participants
Where
1 siteIndia
Study dates
Jun 2015to Dec 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

India1 site

  • Dr Budhi Singh Yadav

    Chandigarh, N/A = Not Applicable, 91 160012

Other trials in India

About this study

Official title: A Phase III Randomized Study Comparing Two Adjuvant Hypofractionated Radiation Schedules in Patients With Breast Cancer

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Hypofractionated Radiation therapy
Keywords
Breast cancer, hypofractionated radiotherapy, Hypofractionated radiation
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypofractionated Radiation therapyRadiation

Study groups in NCT04075058
Study groupRoleWhat they receive
StudyExperimentalPatients 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.
Receives: Radiation: Hypofractionated Radiation therapy
ControlActive comparatorPatients 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
Receives: Radiation: Hypofractionated Radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local Recurrence

    Any recurrence with in the irradiated area from completion of radiation

    Measured: 5 years

Secondary outcomes (10)

  1. Acute skin toxicity

    Acute toxicity will be assessed using a RTOG grading system. Assessment will be carried out weekly during radiotherapy and for 4 weeks after treatment.

    Measured: After 1 month of completion of radiation

  2. Cosmetic assessment

    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.

    Measured: Baseline, 1 year, 3 years, 5 years

  3. Quality of life

    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.

    Measured: 3 year, 5 year

  4. Quality of life

    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.

    Measured: 3 year, 5 year

  5. Disease free survival

    Time interval free from locoregional recurrence and metastasis

    Measured: 5 years, 10 years

  6. Overall survival

    From the date of diagnosis to death

    Measured: 5 years, 10 years

  7. Arm edema

    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.

    Measured: 3 years, 5 years, 10 years

  8. Late effects- pain, shoulder stiffness

    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).

    Measured: 3 years, 5 years, 10 years

  9. Late effects- Brachial plexopathy

    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.

    Measured: 3 years, 5 years, 10 years

  10. Late effects- Lung, cardiac

    Late lung and cardiac toxicity asess all late effects according to the RTOG LENT SOMA scale (Cox et al, 1995).

    Measured: 5 years, 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2019
  2. Study startJun 2015
  3. Primary completionDec 2020
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,070 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04075058
Sponsor's protocol ID
HRBC
Acronym
HRBC
Status last verified
Jun 2021
First submitted
26 Oct 2015
Last updated
23 Jun 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Yadav BS. Accelerated partial breast irradiation. Radiother Oncol. 2009 Jan;90(1):161. doi: 10.1016/j.radonc.2007.10.005. Epub 2007 Oct 25. No abstract available.

    PubMed 17963907

  • Yadav BS, Sharma SC, Patel FD, Ghoshal S, Kapoor RK. Second primary in the contralateral breast after treatment of breast cancer. Radiother Oncol. 2008 Feb;86(2):171-6. doi: 10.1016/j.radonc.2007.10.002. Epub 2007 Oct 24.

    PubMed 17961777

  • Yadav BS, Sharma SC, George P, Bansal A. Post-mastectomy radiation beyond chest wall in patients with N1 breast cancer: is there a benefit? J Cancer Res Ther. 2014 Apr-Jun;10(2):279-83. doi: 10.4103/0973-1482.136560.

    PubMed 25022378

  • Yadav BS, Sharma SC, Patel FD, Ghoshal S, Kapoor R, Kumar R. Nonbreast second malignancies after treatment of primary breast cancer. Int J Radiat Oncol Biol Phys. 2009 Apr 1;73(5):1489-92. doi: 10.1016/j.ijrobp.2008.07.004. Epub 2008 Sep 19.

    PubMed 18804919

  • Yadav BS, Dahiya D, Gupta M, Gupta A, Oinam AS, Khare S, Irrinki S, Robert N, Sakaray YR, Nagaraj SS, Kumari R. Preliminary results of hypofractionated radiotherapy in breast cancer in Chandigarh, India: single-centre, non-inferiority, open-label, randomised, phase 3 trial. Lancet Reg Health Southeast Asia. 2024 Mar 21;24:100392. doi: 10.1016/j.lansea.2024.100392. eCollection 2024 May.

    PubMed 38550605

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hypofractionated Radiation therapy in people with Breast Cancer, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local Recurrence (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04075058, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.

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