Hypofractionated Radiation Therapy in Patients With Breast Cancer

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

PHASE3

Total Enrollment

1070 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Hypofractionated Radiation therapy

Intervention Type RADIATION

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

Group Type ACTIVE_COMPARATOR

Hypofractionated Radiation therapy

Intervention Type RADIATION

Interventions

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Hypofractionated Radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No