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Hypo-Fractionated Radiotherapy in Breast Cancer

NCT ID: NCT03669497

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2021-09-06

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Advanced Breast Cancer Metastatic Breast Cancer

Keywords

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Palliative Radiotherapy Hypo-fractionated Radiotherapy Simultaneous integrated boost

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypo fractionated radiotherapy

Hypo fractionated whole breast radiotherapy with simultaneous integrated boost to the tumour

Group Type EXPERIMENTAL

Hypo fractionated whole breast radiotherapy

Intervention Type RADIATION

Hypo fractionated radiotherapy to the whole breast and SCF to a dose of 26 GY in 5 fractions with simultaneous integrated boost in advanced incurable breast cancer

Interventions

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Hypo fractionated whole breast radiotherapy

Hypo fractionated radiotherapy to the whole breast and SCF to a dose of 26 GY in 5 fractions with simultaneous integrated boost in advanced incurable breast cancer

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tata Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sanjoy Chatterjee

Kolkata, West Bengal, India

Site Status

Countries

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India

Other Identifiers

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EC/TMC/108/17

Identifier Type: -

Identifier Source: org_study_id