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Palliative Hypofractionated Radiotherapy in Advanced Incurable Breast Cancer

NCT03511781 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-12-17

No results posted yet for this study

Summary

This prospective phase I/II study to assess the clinical toxicity and investigate the clinical response of breast cancers to a 10 fraction hypofractionated course of radiation therapy in advanced incurable breast cancer patients. This study would also investigate the feasibility of voluntary breath hold technique for heart sparing in left sided breast cancer patients. An intervention radiation therapy dose of 35 Gray in 10 fractions over 2 weeks, 5 fractions per week, 1 fraction per day will be studied within this clinical trial. Primary objective of the study is to assess the toxicity using CTCAE version 4 and LENTSOMA toxicity criteria, in advanced incurable breast cancer patients treated with hypofractionated radiotherapy schedule of 35 GY in 10 fractions . Secondary objectives are 1. response rate after radiotherapy measured using the PERCIST criteria at 3 months. 2. Change in quality of life measured using trial outcome index (TOI) at 2 weeks after radiotherapy. 3. Measure the change in PHQ4 score at 2 weeks after radiotherapy.

Additionally to assess the feasibility of voluntary breath hold technique for heart sparing in left sided breast cancer patients and to biobank tissue and blood for future radiobiology tests. A total of 30 patients will be recruited in this study. Among these 30 patients at least 10 patients will be recruited with left sided breast cancer on which feasibility of voluntary breath hold technique for heart sparing will be tested. Patient will be followed up weekly during radiotherapy, then monthly for 1st three months, then 3 monthly for two years, then 6 monthly for next 3 years.

Conditions

  • Carcinoma Breast Stage IV

Interventions

RADIATION

Hypofractionated Radiotherapy

Palliative Hypofractionated radiotherapy 35 GY in 10 fractions over 2 weeks in advanced incurable Breast Cancer

Sponsors & Collaborators

  • Tata Medical Center

    lead OTHER

Principal Investigators

  • Sanjoy Chatterjee, FRCP,FRCR · Tata Medical Center,Kolkata

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2020-10-31
Completion
2021-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03511781 on ClinicalTrials.gov