Hypofractionated Radiation Therapy in Patients With Breast Cancer

NCT04075058 | Completed Phase 3 DMC

• 1 other identifier: HRBC
• Study Type: interventional
• Target: 1,070
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; hypofractionated radiotherapy; Hypofractionated radiation

Outcome Measures

Primary Outcomes (1)

• Local Recurrence

  Any recurrence with in the irradiated area from completion of radiation

  5 years

Secondary Outcomes (10)

• Acute skin toxicity

  After 1 month of completion of radiation

• Cosmetic assessment

  Baseline, 1 year, 3 years, 5 years

• Quality of life

  3 year, 5 year

• Quality of life

  3 year, 5 year

• Disease free survival

  5 years, 10 years

Study Arms (2)

Study

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Hypofractionated Radiation therapy RADIATION

Control; Study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Dr Budhi Singh Yadav

Chandigarh, N/A = Not Applicable, 91 160012, India

Location

Related Publications (5)

• 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.

  PMID: 17963907 BACKGROUND

• 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.

  PMID: 17961777 BACKGROUND

• 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.

  PMID: 25022378 RESULT

• 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.

  PMID: 18804919 RESULT

• 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.

  PMID: 38550605 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Budhi S Yadav, MD

  PGIMER, Chandigarh, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: August 30, 2019
• Study Start: June 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

IN (1)