1. Home
  2. Approved trials
  3. » فارسی

A clinical trial evaluating the results and complications of intraoperative radiotherapy as boost after neoadjuvant chemotherapy in patients with nonmetastatic breast cancer candidate for breast conserving surgery

Protocol summary

Summary
This study will assess results of intraoperative radiotherapy as boost after neoadjuvant chemotherapy in patients with nonmetastatic breast cancer candidate for breast conserving surgery. Recruitment will be done in three treatment centers. Major inclusion criteria comprise of female gender; age between 30 and 70 years; and operable breast cancer patient who is candidate for breast conserving surgery. Major exclusion criterion consist of pregnancy and breast feeding; active collagen vascular diseases; previous history of chest wall radiotherapy; multifocal breast cancer in two separate quadrants of breast; and poor clinical response to the neoadjuvant chemotherapy. The study is unblinded, single-grouped, and prospective. Twenty patients will be incorporated using convenience sampling method and assessed by complete history taking and physical examination, bilateral mammography, and breast/axilla sonography and metastases work-up before the intervention. Then, a detectable marker will be inserted under the guide of sonography in the tumor. Afterwards, the patients will receive neoadjuvant chemotherapy based on the standards of the treating institute. Before each course of chemotherapy, the patients will be examined for clinical response to chemotherapy. At the end of neoadjuvant treatment, the patients will undergo full physical examination and mammographic and sonographic assessment. In case of appropriate clinical response, the patients will undergo lumpectomy two weeks after completion of neoadjuvant treatment. During surgery, the patients will receive 20 gray intraoperative radiotherapy by intrabeam system Zeiss. After surgery, the patients will receive external beam radiotherapy (50 gray to the whole breast and 45 to 50 gray to the supraclavicular lymph node). Patients will be followed up every 3 months during the first 2 year, and then every 6 months until 5 years by physical examination and annual mammography (or sonography in case of dense breast). Patients will be analyzed based on complications of treatment and two-year disease-free survival.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017091428815N2
Registration date: 2017-09-28, 1396/07/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-28, 1396/07/06
Registrant information
Name
Seyed Alireza Javadinia
Name of organization / entity
Department of Oncology, Omid Hospital, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2736
Email address
javadiniaa941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellery of Research and Technology, Mashhad University of Medical Sciences
Expected recruitment start date
2017-02-09, 1395/11/21
Expected recruitment end date
2018-12-31, 1397/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial evaluating the results and complications of intraoperative radiotherapy as boost after neoadjuvant chemotherapy in patients with nonmetastatic breast cancer candidate for breast conserving surgery
Public title
Results and complications of intraoperative radiotherapy as boost after neoadjuvant chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women between 30 and 70 years old; informed consent for participation; pathologic confirmation of invasive ductal carcinoma of breast; tumor stages of T3N1M0, T3N0M0, T2N1M0, and T2N0M0 based on classification of American Joint Committee on Cancer; and operable breast cancer patient who is candidate for breast conserving surgery. Exclusion criteria: Pregnancy and breast feeding; active collagen vascular diseases like scleroderma; history of chest wall radiotherapy for Hodgkin lymphoma; multifocal breast cancer in two separate quadrants of breast; presence of metastasis during treatment; and poor clinical response to the neoadjuvant chemotherapy.
Age
From 30 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice-chancellery for Research, Mashhad University of Medical Sciences, Daneshgah Ave.,
City
Mashhad
Postal code
Approval date
2017-02-08, 1395/11/20
Ethics committee reference number
IR.MUMS.fm.REC.1395.545

Health conditions studied

1

Description of health condition studied
Breast cancer
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified

Primary outcomes

1

Description
two-year disease-free survival
Timepoint
every 3 months
Method of measurement
physical examination and mammography

Secondary outcomes

1

Description
Dermatitis
Timepoint
every 3 months in the first two years; every 6 months in the third to fifth years after intervention
Method of measurement
physical examination

2

Description
Skin necrosis
Timepoint
every 3 months in the first two years; every 6 months in the third to fifth years after intervention
Method of measurement
physical examination

3

Description
Beauty
Timepoint
every 3 months in the first two years; every 6 months in the third to fifth years after intervention
Method of measurement
physical examination

Intervention groups

1

Description
a detectable marker will be inserted under the guide of sonography in the tumor. Afterwards, the patients will receive neoadjuvant chemotherapy based on the standards of the treating institute. Before each course of chemotherapy, the patients will be examined for clinical response to chemotherapy. At the end of neoadjuvant treatment, the patients will undergo full physical examination and mammographic and sonographic assessment. In case of appropriate clinical response, the patients will undergo lumpectomy two weeks after completion of neoadjuvant treatment. During surgery, the patients will receive 20 gray intraoperative radiotherapy by intrabeam system Zeiss. After surgery, the patients will receive external beam radiotherapy (50 gray to the whole breast and 45 to 50 gray to the supraclavicular lymph node). Patients will be followed up every 3 months during the first 2 year, and then every 6 months until 5 years by physical examination and annual mammography (or sonography in case of dense breast).
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid Radiation Oncology Hospital
Full name of responsible person
Dr Fatemeh Homaee Shandiz
Street address
Koohsangi Ave.,
City
Mashhad

2

Recruitment center
Name of recruitment center
Radiotherapy Ward of Imam Reza Hospital
Full name of responsible person
Dr Fatemeh Homaee Shandiz
Street address
Daneshgah Ave.,
City
Mashhad

3

Recruitment center
Name of recruitment center
Pasteur Hospital
Full name of responsible person
Dr Fatemeh Homaee Shandiz
Street address
Pasteur Ave.,
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellery for Research of Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Daneshgah Ave.
City
Mashhad
Grant name
Grant code / Reference number
950125
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellery for Research of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Omid Hospital
Full name of responsible person
Dr Alireza Keramati
Position
Resident of radiooncology
Other areas of specialty/work
Street address
Koohsangi Ave.
City
Mashhad
Postal code
917661377
Phone
+98 51 3842 6083
Fax
Email
keramatia941@mums.ac.ir
Web page address
http://research.mums.ac.ir/webdocument/load.action?webdocument_code=8000&masterCode=8011904

Person responsible for scientific inquiries

Contact
Name of organization / entity
Omid Hospital
Full name of responsible person
Dr Fatemeh Homaee Shandiz
Position
Radiooncologist
Other areas of specialty/work
Street address
Koohsangi Ave.
City
Mashhad
Postal code
Phone
+98 51 3842 6083
Fax
Email
@mums.ac.irHomaeeF
Web page address
http://research.mums.ac.ir/webdocument/load.action?webdocument_code=8000&masterCode=8000815

Person responsible for updating data

Contact
Name of organization / entity
Radiation Oncology Department, Faculty of Medicine, Mashhad University of Medical Sciences
Full name of responsible person
Dr Seyed Alireza Javadinia
Position
Resident of radiooncology
Other areas of specialty/work
Street address
Department of Oncology, Imam Reza Hospital, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 3842 6083
Fax
Email
Javadiniaa941@mums.ac.ir
Web page address
http://research.mums.ac.ir/webdocument/load.action?webdocument_code=8000&masterCode=8011136

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...