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One Week Adjuvant Radiotherapy for Breast Cancer

Primary Purpose

Breast Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Hypofractionation Radiotherapy.

Ultra-hypofractionation radiotherapy

About this trial

This is an interventional treatment trial for Breast Carcinoma

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female patients 45 years of age or older who have had Oncoplastic Breast Surgery (OBS) or total mastectomy with adequate axillary clearance and a negative margin.
Breast carcinomas that is invasive (TXN1-3M0, T0N2-3 M0, T1N2-3M0, T2N2-3M0, T3N0-3M0, T4N0-3M0) whatever type of tumors biology.
All patients with locally advanced breast cancer who received neoadjuvant chemotherapy and underwent either oncoplastic breast surgery or modified radical mastectomy

Exclusion Criteria:

Metastatic breast cancer at the time of diagnosis proved clinically or radiologically.
Postoperative positive margin.
Carcinomas in situ.
Mesenchymal breast lesions.
Locoregional recurrent breast cancer.
Synchronous bilateral breast cancer.
very early breast cancer (T1-2N0M0,T1N1M0).

Sites / Locations

Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hypofractionation control arm

. Ultrahypofractionation experimental arm

Arm Description

Patients who will receive 40 Gy in 15 fractions to the entire breast or chest wall over three weeks and have had breast conservation surgery (BCS) or oncoplastic breast surgery(OBS) will receive an additional boost to the tumour site if and will receive sequential dose 12GY\4 fractions or SIB 8GY 15 fractions. The supraclavicular fossa will be treated in patients with node-positive disease or those who had received neoadjuvant chemotherapy . The IMLN will be irradiated in N2and N3 at first presentation.

Patients who will receive 26 Gy in 5 fractions to the entire breast and or chest wall for one week only. The volume of this arm will be the same as the volume of the control arm as regard axillary nodes, supraclavicular and IMLN. Patients who have had breast conservation or oncoplastic breast surgery(OBS) will be given a boost. If a boost is given, SIB of 6 Gy in 5 fractions will be used (or a sequential boost of 12GY\4 fractions).

Outcomes

Primary Outcome Measures

Acute toxicity

Rate of acute grade 2 toxicity or higher from the treatment till 3 months (NCI_CTCAE). Each patient will be assesed weekly during radiotherapy and monthly for 3 months post radiotherapy.

Chronic toxicity

Rate of chronic toxicity grade 2 or higher ( NCI_CTCAE) from 6 months after radiotherapy up to 2 years. Each patient will be assessed before treatment and at 6,12 and 24 months from treatment.

Local recurrence

Rate of ipsilateral locoregional tumor recurrence proved by imaging and biopsy.

Patient compliance

Compliance to treatment (number of interrupted days of radiotherapy.

Secondary Outcome Measures

Overall survival

Overall survival (Number of the surviving patients for 2 years in each arm of the study)

Full Information

NCT ID

NCT05150535

First Posted

November 3, 2021

Last Updated

May 5, 2022

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05150535

Brief Title

One Week Adjuvant Radiotherapy for Breast Cancer

Official Title

A Prospective Study of One Week Accelerated Hypo-fractionation Adjuvant Radiotherapy in High-risk Breast Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

October 1, 2023 (Anticipated)

Study Completion Date

October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Cancer is the second leading cause of death after cerebrovascular strokes and is a significant obstacle to each nation's future growth. Worldwide, Breast cancer is the most common cancer in women and the 5th leading cause of cancer related deaths that comes after lung cancer, colorectal cancer, liver cancer and gastric cancer. More than half of all breast cancer cases in the world occur in developing countries. Egypt has a high mortality rate from breast cancer, with a rate of 21.3 per 100,000 cases. Breast cancer is diagnosed at an advanced stage in 60 to 70% of cases in Egypt. The median age at diagnosis in Egypt is 48.5 years, which seems to be a decade younger than in Europe and North America.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hypofractionation control arm

Arm Type

Active Comparator

Arm Description

Arm Title

. Ultrahypofractionation experimental arm

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Hypofractionation Radiotherapy.

Other Intervention Name(s)

3 weeks radiotherapy.

Intervention Description

Patients will receive 40 Gy in 15 fractions to the entire breast and or chest wall over the course of 3 weeks.

Intervention Type

Radiation

Intervention Name(s)

Ultra-hypofractionation radiotherapy

Other Intervention Name(s)

1 week accelerated hypo-fractionation radiotherapy

Intervention Description

Patients will receive 26 Gy in 5 fractions to the entire breast and or chest wall over the course of one week.

Primary Outcome Measure Information:

Title

Acute toxicity

Description

Rate of acute grade 2 toxicity or higher from the treatment till 3 months (NCI_CTCAE). Each patient will be assesed weekly during radiotherapy and monthly for 3 months post radiotherapy.

Time Frame

3 months

Title

Chronic toxicity

Description

Rate of chronic toxicity grade 2 or higher ( NCI_CTCAE) from 6 months after radiotherapy up to 2 years. Each patient will be assessed before treatment and at 6,12 and 24 months from treatment.

Time Frame

6 months post treatment up to 2 years

Title

Local recurrence

Description

Rate of ipsilateral locoregional tumor recurrence proved by imaging and biopsy.

Time Frame

Up to 2 years

Title

Patient compliance

Description

Compliance to treatment (number of interrupted days of radiotherapy.

Time Frame

From the starting point of treatment till the end of treatment ( 3 weeks in control arm and 1 week in experimental arm

Secondary Outcome Measure Information:

Title

Overall survival

Description

Overall survival (Number of the surviving patients for 2 years in each arm of the study)

Time Frame

From time of diagnosis up to 2 years post radiotherapy

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

female adult patients with breast

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female patients 45 years of age or older who have had Oncoplastic Breast Surgery (OBS) or total mastectomy with adequate axillary clearance and a negative margin. Breast carcinomas that is invasive (TXN1-3M0, T0N2-3 M0, T1N2-3M0, T2N2-3M0, T3N0-3M0, T4N0-3M0) whatever type of tumors biology. All patients with locally advanced breast cancer who received neoadjuvant chemotherapy and underwent either oncoplastic breast surgery or modified radical mastectomy Exclusion Criteria: Metastatic breast cancer at the time of diagnosis proved clinically or radiologically. Postoperative positive margin. Carcinomas in situ. Mesenchymal breast lesions. Locoregional recurrent breast cancer. Synchronous bilateral breast cancer. very early breast cancer (T1-2N0M0,T1N1M0).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nahla M Elmahdy, assistant lecturer

Phone

01026886840

nahla.youssif@med.sohag.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed S gaber, professor

Facility Information:

Facility Name

Sohag University Hospital

City

Sohag

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Osama R ElSherif, professor

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

33538338

Citation

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.

Results Reference

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PubMed Identifier

32221669

Citation

Gany F, Ayash C, Raad N, Wu M, Roberts-Eversley N, Mahmoud H, Fouad Y, Fahmy Y, Asar H, Salama A, El-Shinawi M. Financial and food security challenges of Egyptian women undergoing breast cancer treatment. Support Care Cancer. 2020 Dec;28(12):5787-5794. doi: 10.1007/s00520-020-05426-9. Epub 2020 Mar 27.

Results Reference

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PubMed Identifier

31040712

Citation

Momenimovahed Z, Salehiniya H. Epidemiological characteristics of and risk factors for breast cancer in the world. Breast Cancer (Dove Med Press). 2019 Apr 10;11:151-164. doi: 10.2147/BCTT.S176070. eCollection 2019.

Results Reference

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PubMed Identifier

29516087

Citation

Stapleton SM, Oseni TO, Bababekov YJ, Hung YC, Chang DC. Race/Ethnicity and Age Distribution of Breast Cancer Diagnosis in the United States. JAMA Surg. 2018 Jun 1;153(6):594-595. doi: 10.1001/jamasurg.2018.0035.

Results Reference

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One Week Adjuvant Radiotherapy for Breast Cancer

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