HYPORT-B: Hypo-Fractionated Radiotherapy in Breast Cancer

Sponsor
Tata Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03669497
Collaborator
(none)
30
1
1
60
0.5

Study Details

Study Description

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
  • Radiation: Hypo fractionated whole breast radiotherapy
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 2, 2018
Actual Primary Completion Date :
Dec 2, 2020
Anticipated Study Completion Date :
Jan 3, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Toxicity (CTCAE v 4.03) [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 [3 months]

    To assess the response 3 months after radiotherapy clinically and by regional PET-CT scan using PERCIST criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sanjoy Chatterjee Kolkata West Bengal India 700160

Sponsors and Collaborators

  • Tata Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tata Medical Center
ClinicalTrials.gov Identifier:
NCT03669497
Other Study ID Numbers:
  • EC/TMC/108/17
First Posted:
Sep 13, 2018
Last Update Posted:
Dec 3, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tata Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2021