2-weeks of Adjuvant Radiotherapy in Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.
    

Intervention name(s): Hypofractionation
Intervention type(s): Radiation
Intervention description(s): Radiation dose of 34Gy in 10 fractions over 2 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; hypofractionation; radiotherapy