Hypo-Fractionated Radiotherapy in Breast Cancer (HYPORT-B)

  • STATUS
    Recruiting
  • End date
    Jan 3, 2023
  • participants needed
    30
  • sponsor
    Tata Medical Center
Updated on 14 February 2022
ct scan
carcinoma
breast cancer
advanced breast cancer
stage iv breast cancer
breast radiotherapy
curative surgery
locally advanced breast cancer
breast carcinoma
invasive breast cancer
female breast cancer
invasive carcinoma

Summary

This is a prospective interventional phase I/II study which will be done at Tata Medical Centre, Kolkata. Total 30 eligible female patients, 18 years of age, with locally advance invasive carcinoma of breast, not amenable to curative surgery of metastatic breast cancer, planned for palliative loco regional radiotherapy will be enrolled in the study amongst which patients with left sided breast cancer (at least 10) will be recruited to study the feasibility of voluntary breath hold technique for heart sparing. Once consented, all patients will have regional baseline PET-CT scan of breast and tissue biopsy along with blood sampling done before studying radiotherapy. Planning Ct scan will then be taken, with standard planning CT scan for right breast cancers with implementation voluntary breath hold technique for the left breast disease. All patients will be treated with hypo-fractionated radiotherapy with schedule of 26Gy on 5 Fractions over 1 week with 6Gy simultaneously integrated boost with incorporation of breath hold technique for left breast disease. All patients will be assessed weekly during course of radiotherapy. The toxicity will be assessed using CTCAE version 4 and LENT SOMA toxicity criteria and the impact of the hypo-fractionated breast radiotherapy schedule on quality of life in advanced incurable breast cancer patients using FACT B scores PHQ4 questionnaire will also be assessed during treatment and follow-ups tissue bio0psy will be taken after 2 hours of completion of 1 st and last fraction of radiotherapy and biobanked for future radiobiological tests. Response evaluation will be done clinically and by regional PET CT scan using PERSIST criteria in 3 months after completion of radiotherapy. After completion of treatment, patient will initially be followed up every month for 1 st three months thereby 3 monthly for 2 years and 6 monthly for next 3 years.

Details
Condition Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer
Treatment Hypo fractionated whole breast radiotherapy
Clinical Study IdentifierNCT03669497
SponsorTata Medical Center
Last Modified on14 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years
Female
Invasive carcinoma of the breast
ECOG performance status 0-2
Locally advanced breast cancer which is not amenable to curative surgery as decided by multidisciplinary tumour board
Metastatic breast cancer patients
Who are awaiting palliative locoregional radiotherapy for symptom (pain bleeding, ulceration, impending fungation) control
Who have completed a scheduled course of palliative chemotherapy and is felt to benefit from local radiation therapy
Able to give informed consent

Exclusion Criteria

Breast reconstruction using implants
Concurrent cyto-toxic chemotherapy
Prior radiation to the chest wall / breast
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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