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Hypo-Fractionated Radiotherapy in Breast Cancer (HYPORT-B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669497
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Tata Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Advanced Breast Cancer Metastatic Breast Cancer Radiation: Hypo fractionated whole breast radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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).
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : December 2, 2020
Estimated Study Completion Date : December 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Hypo fractionated radiotherapy
Hypo fractionated whole breast radiotherapy with simultaneous integrated boost to the tumour
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




Primary Outcome Measures :
  1. Toxicity (CTCAE v 4.03) [ Time Frame: 3 months ]
    Proportion of patients with Grade 3 or more toxicity at 3 months evaluated as per the CTCAE v 4.03 criteria.


Secondary Outcome Measures :
  1. Response [ Time Frame: 3 months ]
    To assess the response 3 months after radiotherapy clinically and by regional PET-CT scan using PERCIST criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669497


Contacts
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Contact: Sanjoy Chatterjee, FRCR 9038161825 ext 7403 sanjoy.chatterjee@tmckolkata.com
Contact: Sanjoy Chatterjee, FRCR 9038161825 ext 7405 chatterjee72@hotmail.com

Locations
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India
Sanjoy Chatterjee Recruiting
Kolkata, West Bengal, India, 700160
Contact: Sanjoy Chatterjee, FRCR    9038161825 ext 7403    sanjoy.chatterjee@tmckolkata.com   
Contact: Sanjoy Chatterjee, FRCR    9038161825 ext 7405    chatterjee72@hotmail.com   
Principal Investigator: Sanjoy Chatterjee, FRCR         
Sub-Investigator: Santam Chakraborty, MD         
Sub-Investigator: Rosina Ahmed, FRCS         
Sub-Investigator: Sanjit Kr. Agarwal, MS         
Sub-Investigator: Avipsa Das, MD         
Sub-Investigator: Soumitra Sankar Datta, CCT         
Sponsors and Collaborators
Tata Medical Center
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Responsible Party: Tata Medical Center
ClinicalTrials.gov Identifier: NCT03669497    
Other Study ID Numbers: EC/TMC/108/17
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tata Medical Center:
Palliative Radiotherapy
Hypo-fractionated Radiotherapy
Simultaneous integrated boost
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases