HYPofractionated Adjuvant RadioTherapy in 1 Versus 2 Weeks in High-risk Patients With Breast Cancer (HYPART): A Non-inferiority, Open-label, Phase III Randomized Trial.

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

We at PGIMER have been practicing hypofractionated radiotherapy in breast cancer patients for the last 4 decades. Our standard doses have been 35Gy/15#/3wks to the chest wall after mastectomy and 40Gy/16#/3wks after breast conserving surgery (BCS).It is also a routine practice in the UK and in a 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 helps radiation centers worldwide to meet the growing need for radiation treatment 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 we want to evaluate the impact of reducing the treatment duration from 3 weeks to 1 week. Eligible patients with breast cancer after mastectomy or BCS will be treated with a radiotherapy dose of 26Gy in 5 fractions over 1 week in the study arm and 40Gy in 15 fractions over 2 weeks in the control arm. The primary endpoint of this noninferiority study will be locoregional tumour control. Secondary endpoints will be early and late radiation toxicities, quality of life, contralateral primary tumours, regional and distant metastases, survival and second cancers. A total of 1018 patients will be randomised (1:1) to receive 1 week or 2 weeks of radiotherapy. An event-driven analysis will be performed after at least 94 patients have documented locoregional recurrences.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• Female or male

• Invasive carcinoma of the breast

• Breast conserving surgery(BCS) with axillary clearance or total mastectomy with axillary clearance(TMAC); (reconstruction allowed but not with implant; tissue expanders with distant metal ports are allowed)

• Concurrent trastuzumab and hormone therapy is allowed

• Axillary staging and/or dissection

• Complete microscopic excision of primary tumour

• pT3-4pN2-3 M0 disease

• Clinical stage III disease or pathological node positive if they have received neo-adjuvant chemotherapy.

⁃ Written informed consent

⁃ Able to comply with follow-up

Locations
Other Locations
India
Budhi Singh Yadav
RECRUITING
Chandigarh
Contact Information
Primary
BUDHI S YADAV, MD
drbudhi@gmail.com
9815981176
Backup
BUDHI S YADAV
drbudhi@gmail.com
9815981176
Time Frame
Start Date: 2021-03-30
Estimated Completion Date: 2028-08-20
Participants
Target number of participants: 1018
Treatments
Experimental: 1 week
Radiotherapy dose to chest wall, axilla level III and supraclavicular fossa will be of 26Gy in 5 fractions over 1 week in the study arm. BCS patients will receive a sequential boost of 8Gy/2#/2days or simultaneous integrated boost(SIB) to a total dose of 34Gy.Supraclavicular fossa(SCF) and axilla level III will be treated in patients with T3-4 disease with lymphovascular invasion, grade 3 or N2 disease and T3-4 disease treated with neoadjuvant chemotherapy after adequate axillary dissection. Level I and II axilla will only be irradiated in patients with inadequate axillary dissection(\<10 lymph nodes). Internal mammary node (IMNs) radiation will be done in T3-4 central and inner quadrant lesions and patients with N2 disease. IMNs will be irradiated with a separate single field. The first five intercostal spaces will be included in the IMN target volume.
Active_comparator: 2 week
Radiotherapy dose to chest wall, axilla level III and supraclavicular fossa will be 34Gy in 10 fractions over 2 weeks in the control arm. BCS patients will receive a sequential boost of 8Gy/2#/2days or simultaneous integrated boost(SIB) to a total dose of 42 Gy.
Related Therapeutic Areas
Sponsors
Leads: Post Graduate Institute of Medical Education and Research, Chandigarh

This content was sourced from clinicaltrials.gov

Similar Clinical Trials