2-weeks of Adjuvant Radiotherapy in Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase II Study of 2-weeks of Adjuvant Whole Breast/Chest Wall and/or Regional Nodal Radiotherapy in Patients With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460744
• Other study ID #: BHRT
• Status: Completed
• Phase: Phase 2
• First received: May 26, 2015
• Last updated: June 1, 2015
• Start date: June 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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 , stage II of breast carcinoma. Twenty 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.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 followed by a boost of 10Gy/5#/1wk in cases with intact breast. Acute toxicity will be assessed using a RTOG grading system. This will be carried out weekly during radiotherapy and for 4 weeks after treatment. If symptoms persist the patients will be assessed weekly until their reaction settles to RTOG grade 1 or less (Annexure I).

Statistical analyses The principle end point of the study is an analysis of acute toxicities, cosmetic score analysis. Skin, subcutaneous toxicity and cosmetic assessment will be done before treatment and then in regular follow up of the study. Chi-square test will be used to compare radiation toxicity parameters. Descriptive statistics including mean and standard deviation will be obtained for all variables. p values of <0.05 will be taken as significant. All tests would be performed using SPSS (Statistical Package for the Social Sciences) v.12.0.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

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)

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
India	Dr Budhi Singh Yadav	Chandigarh	N/A = Not Applicable

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute skin and subcutaneous toxicity assessed using a RTOG grading system	Acute toxicity will be assessed using a RTOG grading system.	1 month	Yes
Secondary	Cosmetic score analysis using Harvard/NSABP/RTOG Breast Cosmesis Grading Scale	Cosmetic score analysis will be done using Harvard/NSABP/RTOG Breast Cosmesis Grading Scale	Base line, one month and 6 months after completion of radiation	Yes