Hypo-Fractionated Radiotherapy in Breast Cancer

Breast Cancer Clinical Trial

— HYPORT-B  

Official title:

Hypo-fractionated Radiotherapy Schedule of 26 GY in 5 Fractions With Simultaneous Integrated Boost (6 GY) in Advanced Incurable Breast Cancer: A Prospective Phase I/II Study (HYPORT-B).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669497
• Other study ID #: EC/TMC/108/17
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: September 6, 2021

Study information

• Verified date: December 2023
• Source: Tata Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective interventional phase I/II study which will be done at Tata Medical Centre, Kolkata. Total 30 eligible female patients, ≥18 years of age, with locally advance invasive carcinoma of breast, not amenable to curative surgery of metastatic breast cancer, planned for palliative loco regional radiotherapy will be enrolled in the study amongst which patients with left sided breast cancer (at least 10) will be recruited to study the feasibility of voluntary breath hold technique for heart sparing. Once consented, all patients will have regional baseline PET-CT scan of breast and tissue biopsy along with blood sampling done before studying radiotherapy. Planning Ct scan will then be taken, with standard planning CT scan for right breast cancers with implementation voluntary breath hold technique for the left breast disease. All patients will be treated with hypo-fractionated radiotherapy with schedule of 26Gy on 5 Fractions over 1 week with 6Gy simultaneously integrated boost with incorporation of breath hold technique for left breast disease. All patients will be assessed weekly during course of radiotherapy. The toxicity will be assessed using CTCAE version 4 and LENT SOMA toxicity criteria and the impact of the hypo-fractionated breast radiotherapy schedule on quality of life in advanced incurable breast cancer patients using FACT B scores PHQ4 questionnaire will also be assessed during treatment and follow-ups tissue bio0psy will be taken after 2 hours of completion of 1 st and last fraction of radiotherapy and biobanked for future radiobiological tests. Response evaluation will be done clinically and by regional PET CT scan using PERSIST criteria in 3 months after completion of radiotherapy. After completion of treatment, patient will initially be followed up every month for 1 st three months thereby 3 monthly for 2 years and 6 monthly for next 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 6, 2021
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Female

• Invasive carcinoma of the breast

• ECOG performance status 0-2

• Locally advanced breast cancer which is not amenable to curative surgery as decided by multidisciplinary tumour board.

• Metastatic breast cancer patients:

• Who are awaiting palliative locoregional radiotherapy for symptom (pain bleeding, ulceration, impending fungation) control.

• Who have completed a scheduled course of palliative chemotherapy and is felt to benefit from local radiation therapy

• Able to give informed consent

Exclusion Criteria:

• Breast reconstruction using implants

• Concurrent cyto-toxic chemotherapy

• Prior radiation to the chest wall / breast

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Cancer
• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Radiation:
• Hypo fractionated whole breast radiotherapy
Hypo fractionated radiotherapy to the whole breast and SCF to a dose of 26 GY in 5 fractions with simultaneous integrated boost in advanced incurable breast cancer

Locations

Country	Name	City	State
India	Sanjoy Chatterjee	Kolkata	West Bengal

Sponsors (1)

Lead Sponsor	Collaborator
Tata Medical Center

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity (CTCAE v 4.03)	Proportion of patients with Grade 3 or more toxicity at 3 months evaluated as per the CTCAE v 4.03 criteria.	3 months
Secondary	Response	To assess the response 3 months after radiotherapy clinically and by regional PET-CT scan using PERCIST criteria	3 months