Comparison of the response rate and adverse effect between two groups of adjuvant short course high dose rate intravaginal brachytherapy vs conventional brachytherapy in primary endometrial cancer
1. To compare the response rate between two groups of adjuvant short course high dose rate intravaginal brachytherapy vs conventional brachytherapy in primary endometrial cancer
2. To compare the adverse effect between two groups of adjuvant short course high dose rate intravaginal brachytherapy vs conventional brachytherapy in primary endometrial cancer
Design
In this double arms-randomized phase II trial, 104 endometrial adenocarcinoma patients who meet the inclusion criteria will be recruited. All of the patients had been underwent total abdominal hysterectomy and bilateral salpyngo-oophorectomy (TAH-BSO). They will be entered in one of the treatment groups including intervention including high dose rate short course intravaginal brachytherapy receiving 5 G for 5 days vs. control group consist of conventional brachytherapy of 7 G weekly for 3 fractions. Treatment result and adverse effects will be explained for the patients and Informed consent will be obtained.
Settings and conduct
Patients who referred to radiation oncology ward of Imam Khomeini cancer institute and Mohebbe Yas hospital during year 2017 will be entered in one of two treatment groups.
Participants/Inclusion and exclusion criteria
Patients with stage 1 or 2 of endometrial adenocarcinoma who have been underwent TAH-BSO and referred to radiation oncology ward of Imam Khomeini cancer institute and Mohebbe Yas hospital and also dose not have any comorbidities and dose not need for other adjuvant therapies.
Intervention groups
The intervention group consists of high dose rate short course intravaginal brachytherapy receiving 5 G for 5 days vs. conventional brachytherapy of 7 G weekly for 3 fractions.
Main outcome variables
Response rate; Adverse effect
General information
Reason for update
Acronym
not indicated
IRCT registration information
IRCT registration number:IRCT20161123031040N4
Registration date:2018-01-24, 1396/11/04
Registration timing:registered_while_recruiting
Last update:2018-01-24, 1396/11/04
Update count:0
Registration date
2018-01-24, 1396/11/04
Registrant information
Name
farnaz amouzgar hashemi
Name of organization / entity
cancer institute
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2518
Email address
amoozfar@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the response rate and adverse effect between two groups of adjuvant short course high dose rate intravaginal brachytherapy vs conventional brachytherapy in primary endometrial cancer
Public title
A comparison between adjuvant short course high dose rate intravaginal brachytherapy vs conventional brachytherapy in primary endometrial cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who suffer from endometrial adenocarcinoma stage 1 or 2
Patient's age will be between 18 to 75 years
Patients who have underwent total abdominal hysterectomy and bilateral sapping-oophorectomy
Karnofski Performance Status should be more than 70
Exclusion criteria:
Patient receive other adjuvant therapies like chemotherapy.
Histological pathology of papillary serous carcinoma or clear cell carcinoma
Presence of commodities like severe hypertension or myocardial infarction
Patient refuses the treatment
Age
From 18 years old to 75 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No 21, Dameshgh St. , Vali - e Asr Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1498789534589
Approval date
2016-07-16, 1395/04/26
Ethics committee reference number
IR.TUMS.IKHC.REC.1395.304
Health conditions studied
1
Description of health condition studied
Endometrial adenocarcinoma
ICD-10 code
C54.1
ICD-10 code description
Malignant neoplasm of endometrium
Primary outcomes
1
Description
Rectal complication
Timepoint
Evaluation of rectal complications 4, 8 and 12 months after vaginal cuff brachytherapy
Method of measurement
History, physical examination and proctosigmoidoscopy if indicated
2
Description
Urinary complications
Timepoint
Evaluation of urinary complications 4, 8 and 12 months after vaginal cuff brachytherapy
Method of measurement
History, physical examination and urine analysis if indicated
3
Description
Vaginal complications
Timepoint
Evaluation of vaginal complications 4, 8 and 12 months after vaginal cuff brachytherapy
Method of measurement
History and physical examination
Secondary outcomes
1
Description
Response rate
Timepoint
Assessment of tumor size at the beginning and 4, 8 and 12 months after vaginal cuff brachytherapy
Method of measurement
Assessment of tumor size through vaginal exam
2
Description
Pelvic recurrence
Timepoint
Assessment of pelvic recurrence 4, 8 and 12 months after vaginal cuff brachytherapy
Method of measurement
History and physical exam
3
Description
Vaginal recurrence
Timepoint
Assessment of vaginal recurrence 4, 8 and 12 months after vaginal cuff brachytherapy
Method of measurement
History and physical exam
Intervention groups
1
Description
High dose rate intravaginal brachytherapy with cylinder with total dose of 25 Gray in 5 continuous days during one week after surgery
Category
Treatment - Other
2
Description
Control group: High dose rate intravaginal brachytherapy with cylinder with total dose of 21 Gray in 3 continuous weeks during one week after surgery
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiation Oncology Department of Imam khomeini Cancer Institute and Moheb e Yas Hospital
Full name of responsible person
Afsane Maddah Safaei
Street address
Radiation Oncology Department, Imam khomeini Cancer Institute, Keshavarz Blvd.,Tehran and Moheb e Yas Hospital, Nejattollahi ave,. Tehran
City
Tehran
Province
Tehran
Postal code
148979466799845
Phone
+98 21 6119 2518
Email
amoozfar@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Afsane Maddah Safaei
Street address
Radiation Oncology Department, Imam khomeini Cancer Institute, Keshavarz Blvd.,Tehran and Moheb e Yas Hospital, Nejattollahi ave,. Tehran
City
Tehran
Province
Tehran
Postal code
14982547894665
Phone
+98 21 6119 2518
Email
amoozfar@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farnaz Amouzgar hashemi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Radiation Oncology Department, Imam khomeini Cancer Institute, Keshavarz Blvd.,Tehran and Moheb e Yas Hospital, Nejattollahi ave,. Tehran
City
Tehran
Province
Tehran
Postal code
14897589245789
Phone
+98 21 6119 2518
Fax
Email
amoozfar@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farnaz Amouzegar Hashemi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Radiation Oncology Department, Imam khomeini Cancer Institute, Keshavarz Blvd.,Tehran and Moheb e Yas Hospital, Nejattollahi ave,. Tehran
City
Tehran
Province
Tehran
Postal code
14897589245789
Phone
+98 21 6119 2518
Fax
Email
amoozfar@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farnaz Amoozgar Hashemi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Radiation Oncology Department, Imam khomeini Cancer Institute, Keshavarz Blvd.,Tehran and Moheb e Yas Hospital, Nejattollahi ave,. Tehran
City
Tehran
Province
Tehran
Postal code
14897589245789
Phone
+98 21 6119 2518
Fax
Email
amoozfar@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Data of other research maybe becomes at risk
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The report of study will be released.
When the data will become available and for how long
It will be after publishing the paper.
To whom data/document is available
The results will be accessible for all.
Under which criteria data/document could be used
To administer in clinical decision making the result will be accessible.
From where data/document is obtainable
To receive the results contact to correspondent.
What processes are involved for a request to access data/document