Simultaneous Integrated Boost With Volumetric Arc Radiotherapy in Patients With Breast Cancer

NCT04072718 | Completed Phase 2 DMC

• 1 other identifier: INT/IEC/2017/127
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The study will include 27 patients to study the dosimetric data and acute toxicity. Patients will be treated by SIB intensity modulated radiotherapy (IMRT) boost to the cavity.The dose to be delivered will be a hypo fractionated regimen of 34Gy/10#/2weeks to the whole breast and 40Gy/10#/2weeks to the tumour bed. The dose to the target and to the OAR will be observed. The acute toxicity and cosmesis will be assessed.

Conditions

Breast Cancer

Keywords

Hypofractioned radiotherapy; Simultaneous integrated boost

Outcome Measures

Primary Outcomes (1)

• Acute radiation toxicities

  Acute skin toxicities will be assessed using RTOG acute toxicity scoring scale after one month of completion of treatment.

  one month after completion of treatment

Secondary Outcomes (3)

• cosmetic score analysis

  6 months, 1 year and 3 years off follow up.

• local control

  3 years

• Late toxicity

  3 years

Study Arms (1)

Single arm

OTHER

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

34 Gy/10#/2wk to the PTV and 40Gy/10#/2 Wk to the PTV SIB with IGRT using Rapid arc technique.

Single arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary cancer of breast of any histology,
• age 18-60 years,
• post BCS,
• KPS \>70,
• no distant metastasis and patients who have or have not received chemotherapy

You may not qualify if:

• History of prior primary malignancy,
• prior irradiation to breast or chest,
• pregnant or lactating women, and
• collagen vascular disease

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Dr Budhi Singh Yadav

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Budhi S Yadav, MD

  Postgraduate Institute of Medical Education & Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: To be treated with hypofractionated radiotherapy of 34Gy in 10 fractions to whole breast and 40Gy in 10fractions to the tumor bed

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: August 28, 2019
• Study Start: August 10, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: July 14, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: At 2 years and will be available till 5 years
• Access Criteria: online

Locations

IN (1)