Clinical trial NCT04075058: Hypofractionated Radiation Therapy in Patients With Breast Cancer
Official title: A Phase III Randomized Study Comparing Two Adjuvant Hypofractionated Radiation Schedules in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast cancer
hypofractionated radiotherapy
Hypofractionated radiation
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2019-08-30
Enrollment: 1070
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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-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.

Eligibility criteria: 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)

Primary outcomes:
measure: Local Recurrence
timeFrame: 5 years
Secondary outcomes:
measure: Acute skin toxicity
timeFrame: After 1 month of completion of radiation
measure: Cosmetic assessment
timeFrame: Baseline, 1 year, 3 years, 5 years
measure: Quality of life
timeFrame: 3 year, 5 year
measure: Quality of life
timeFrame: 3 year, 5 year
measure: Disease free survival
timeFrame: 5 years, 10 years
measure: Overall survival
timeFrame: 5 years, 10 years
measure: Arm edema
timeFrame: 3 years, 5 years, 10 years
measure: Late effects- pain, shoulder stiffness
timeFrame: 3 years, 5 years, 10 years
measure: Late effects- Brachial plexopathy
timeFrame: 3 years, 5 years, 10 years
measure: Late effects- Lung, cardiac
timeFrame: 5 years, 10 years
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Dr Budhi Singh Yadav
state: N/A = Not Applicable
Study officials:
affiliation: PGIMER, Chandigarh, India
name: Budhi S Yadav, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.