Accelerated Hypofractionated 1 Week Radiotherapy in Breast Cancer Patients

NCT05591456 | Completed Phase 3

• 1 other identifier: Radiotherapy in Breast Cancer
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Accelerated hypofractionated 1 week post-mastectomy chest wall irradiation in breast cancer patients will presumably produce comparable toxicity and disease control in comparison to 3 weeks schedule. The aim is to evaluate toxicity and disease control after implementation of accelerated hypofractionated 1 week chest wall irradiation in breast cancer patients.

Conditions

Breast Cancer Radiotherapy

Outcome Measures

Primary Outcomes (6)

• detection of breast shrinkage

  breast size measured before and after radiotharapy

  three months after radiotherapy

• detection of breast shrinkage

  breast size measured before and after radiotharapy

  6 months after radiotherapy

• breast on the treated side is indurated

  the induration detected by palpation with comparison with the normal side

  3 months after radiotherapy

• detection of irregularity of breast shape

  change in the normal shape of the breast detected by inspection and photogaphing before and after radiotherapy

  3 months after radiotherapy

• breast on the treated side is indurated

  the induration detected by palpation with comparison with the normal side

  6 months after radiotherapy

• detection of irregularity of breast shape

  change in the normal shape of the breast detected by inspection and photogaphing before and after radiotherapy

  6 months after radiotherapy

Study Arms (2)

group 1

EXPERIMENTAL

The first group 50 patient (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week,

Radiation: adjuvant radiotherapy

group 2

ACTIVE COMPARATOR

the second group 50 patient (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.

Radiation: adjuvant radiotherapy

Interventions

adjuvant radiotherapy RADIATION

Treatment schedule and delivery The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.

group 1; group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histological diagnosis of breast adenocarcinoma
• prior modified radical mastectomy
• negative resection margins (3 mm)
• pathological stage pT1-pT2, N0-2 (AJCC, 2017)
• no macroscopic evidence of distant metastases at diagnosis
• Age 18-80 years
• Normal hematological and biochemical laboratory tests
• Written informed consent was obtained from all patients

You may not qualify if:

• locally advanced disease pT3-pT4, N3
• positive surgical margins
• prior thoracic radiation
• synchronous second primary tumor
• distant metastases
• pregnancy
• presence of a concomitant psychiatric disorder precluding an aware informed consent.
• age \>80 years

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university hospitals

Zagazig, Sharqia Province, 44511, Egypt

Location

Related Publications (6)

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

• Ash DV, Benson EA, Sainsbury JR, Round C, Head C. Seven-year follow-up on 334 patients treated by breast conserving surgery and short course radical postoperative radiotherapy: a report of the Yorkshire Breast Cancer Group. Clin Oncol (R Coll Radiol). 1995;7(2):93-6. doi: 10.1016/s0936-6555(05)80808-8.

  PMID: 7619770 BACKGROUND

• Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.

  PMID: 25328522 BACKGROUND

• Fajdic J, Djurovic D, Gotovac N, Hrgovic Z. Criteria and procedures for breast conserving surgery. Acta Inform Med. 2013 Mar;21(1):16-9. doi: 10.5455/AIM.2013.21.16-19.

  PMID: 23572855 BACKGROUND

• Aleknavicius E, Atkocius V, Kuzmickiene I, Steponaviciene R. Postmastectomy internal mammary nodal irradiation: a long-term outcome. Medicina (Kaunas). 2014;50(4):230-6. doi: 10.1016/j.medici.2014.09.010. Epub 2014 Oct 7.

  PMID: 25458960 BACKGROUND

• Mannino M, Yarnold JR. Shorter fractionation schedules in breast cancer radiotherapy: clinical and economic implications. Eur J Cancer. 2009 Mar;45(5):730-1. doi: 10.1016/j.ejca.2009.01.024. Epub 2009 Feb 23. No abstract available.

  PMID: 19243933 BACKGROUND

MeSH Terms

Interventions

Radiotherapy, Adjuvant

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Radiotherapy

Study Officials

• Rawda Balata, dr

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 24, 2022
• Study Start: January 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: October 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)