Palliative Hypofractionated Radiotherapy in Advanced Incurable Breast Cancer

NCT03511781 | Completed DMC

• 1 other identifier: EC/TMC/31/14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with CTCAE 4.03 defined Grade 3 or more toxicity

  The proportion of patients with CTCAE 4.03 defined Grade 3 or more toxicity related to radiotherapy will be assesed. This will include toxicities like radiation fibrosis, lymphedema, pneumonitis and brachial plexopathy.

  2 Years

Study Arms (1)

Single Arm study

EXPERIMENTAL

Hypofractionated Radiotherapy Schedule of 35 GY in 10 fractions is being administered in advanced Incurable Breast Cancer for female patients

Radiation: Hypofractionated Radiotherapy

Interventions

Hypofractionated Radiotherapy RADIATION

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

Single Arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Invasive carcinoma of the breast 2.ECOG performance Status:0,I,II 3a.Locally Advanced breast cancer which is not amenable to curative surgery as decided by Multidisciplinary tumor board OR 3b.Metastatic breast cancer patients: i) who are awaiting palliative locoregional radiotherapy for symptom (pain,bleeding,ulceration) ii) who have completed a scheduled course of palliative chemotherapy and is felt to benefit from local radiation therapy 4.Able to give consent

You may not qualify if:

• Breast reconstruction using implants
• Concurrent cyto-toxic chemotherapy -

Sponsors & Collaborators

• Tata Medical Center: lead

Study Sites (1)

Tata Medical Center

Kolkata, West Bengal, 700156, India

Location

Related Publications (2)

• Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.

  PMID: 16360786 BACKGROUND

• Darby SC, Ewertz M, McGale P, Bennet AM, Blom-Goldman U, Bronnum D, Correa C, Cutter D, Gagliardi G, Gigante B, Jensen MB, Nisbet A, Peto R, Rahimi K, Taylor C, Hall P. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med. 2013 Mar 14;368(11):987-98. doi: 10.1056/NEJMoa1209825.

  PMID: 23484825 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Sanjoy Chatterjee, FRCP,FRCR

  Tata Medical Center,Kolkata

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: April 30, 2018
• Study Start: September 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: March 1, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

IN (1)