2-weeks of Adjuvant Radiotherapy in Patients With Breast Cancer

NCT02460744 | Completed Phase 2

• 1 other identifier: BHRT
• Study Type: interventional
• Target: 50
• 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 20 patients 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. Patients will be assessed for acute radiation toxicity weekly during treatment and after one month of completion of treatment.

Conditions

Breast Cancer

Keywords

Breast cancer; hypofractionation; radiotherapy

Outcome Measures

Primary Outcomes (1)

• acute skin and subcutaneous toxicity assessed using a RTOG grading system

  Acute toxicity will be assessed using a RTOG grading system.

  1 month

Secondary Outcomes (1)

• Cosmetic score analysis using Harvard/NSABP/RTOG Breast Cosmesis Grading Scale

  Base line, one month and 6 months after completion of radiation

Study Arms (1)

Single arm treatment with radiation

EXPERIMENTAL

Patients with breast cancer will be given adjuvant hypofractionated radiotherapy

Radiation: Hypofractionation

Interventions

Hypofractionation RADIATION

Radiation dose of 34Gy in 10 fractions over 2 weeks.

Single arm treatment with radiation

Eligibility Criteria

• Age: 18 Years - 85 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 (reconstruction allowed but not with implant. Tissue expanders with distant metal ports are allowed)
• 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 N.B. Concurrent trastuzumab and hormone therapy is allowed

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 (1)

• Yadav BS, Sharma SC. A Phase 2 Study of 2 Weeks of Adjuvant Whole Breast/Chest Wall and/or Regional Nodal Radiation Therapy for Patients With Breast Cancer. Int J Radiat Oncol Biol Phys. 2018 Mar 15;100(4):874-881. doi: 10.1016/j.ijrobp.2017.12.015. Epub 2017 Dec 16.

  PMID: 29485066 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Budhi S Yadav, MD

  PGIMER, Chandigarh, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: June 2, 2015
• Study Start: June 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 2, 2015

Record last verified: 2015-05

Locations

IN (1)