acute and subacute complications of short course brachytherapy compared with conventional brachytherapy treatment in patients with cervical cancer after completion of external radiotherapy
acute and subacute complications including cystitis, proctitis and vaginitis of short course brachytherapy compared with conventional brachytherapy treatment of patients with cervical cancer
Design
The study was a non-randomized clinical trial among 49 patients with cervical cancer in stages one to four.
Settings and conduct
cervical cancer patients who referred to Imam Khomeini hospital were non randomly divided in 2 groups of intervention and control for brachytherapy after external chemoradiation
Participants/Inclusion and exclusion criteria
inclusion criteria:
cervical cancer,Age less than 70 years ,Histology of squamous cell carcinoma and adenocarcinoma,Appropriate clinical performance status, clinical disease stage one to four,Hemoglobin higher than or equal to 10;
exclusion criteria:
Recurrences,Those who have received other treatments such as surgery.
Intervention groups
intervention group: 3 high dose rate brachytherapy sessions by multi source device built by BEBIG company were administered every other day during 1 week to reducing overall treatment time.applicators were including tandem ovoid and tandem cylinder needle depended on response to external radiation. brachytherapy is a kind of radiotherapy that involves placing radioactive material(radium) inside body(cervix). We administrated 85-90Gray to high risk Clinical Target Volume and 70-75Gray to Intermediate Risk clinical target volume. Control group. 3 brachytherapy sessions by multi source device built by BEBIG company were administered 1 session every week during 3 week. administration dose was similar in both groups.
Main outcome variables
cystitis، proctitis ،vaginitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200617047815N1
Registration date:2020-08-22, 1399/06/01
Registration timing:retrospective
Last update:2020-08-22, 1399/06/01
Update count:0
Registration date
2020-08-22, 1399/06/01
Registrant information
Name
maryam garousi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2288 4548
Email address
garousi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
2017-04-09, 1396/01/20
Actual recruitment end date
2019-02-18, 1397/11/29
Trial completion date
2019-04-04, 1398/01/15
Scientific title
acute and subacute complications of short course brachytherapy compared with conventional brachytherapy treatment in patients with cervical cancer after completion of external radiotherapy
Public title
Comparison of treatment outcomes and complications of short-term and long-term brachytherapy in patients with cervical cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age less than 70 years old
histopathology Adenocarcinoma & squamous cell carcinoma
suitable performance status
Stage 1b-4a
hemoglobin more than 10
Cervical cancer patients
Females
Exclusion criteria:
Recurrent disease
other treatment procedure like surgery
Age
From 20 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Actual sample size reached:
49
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
Tehran university of Medical Sciences;Poursina Street,Tehran , Tehran Province,
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2018-07-22, 1397/04/31
Ethics committee reference number
IR.TUMS.IKHC.REC.1397.085
Health conditions studied
1
Description of health condition studied
Cervical Cancer
ICD-10 code
C53
ICD-10 code description
Malignant neoplasm of cervix uteri
Primary outcomes
1
Description
the rate of cystitis based on common terminology criteria for adverse events
Timepoint
assess the symptoms before brachytherapy, 0- 30 - 90 days after treatment
Method of measurement
Side effects were recorded by radiation oncologist using the Common terminology criteria for adverse events(CTCAE) guideline.
2
Description
the rate of proctitis based on common terminology criteria for adverse events
Timepoint
assess the symptoms before brachytherapy, 0- 30 - 90 days after treatment
Method of measurement
Side effects were recorded by radiation oncologist using the Common terminology criteria for adverse events(CTCAE) guideline.
3
Description
the rate of vaginitis based on common terminology criteria for adverse events
Timepoint
assess the symptoms before brachytherapy, 0- 30 - 90 days after treatment
Method of measurement
Side effects were recorded by radiation oncologist using the Common terminology criteria for adverse events(CTCAE) guideline.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We performed pelvic MRI for each patient to determine stage of cancer. Then according to three dimensional planing and physics calculation, study participants were treated with external chemoradiation (50 Gy in 25 fractions) with a linear accelerator. They also received weekly Cisplatin for 5 weeks.MRI was done immediately after completion of external chemoradiation . three high dose rate brachytherapy sessions by afterloading multi source device built by BEBIG company were administered every other day during 1 week for reducing overall treatment time.brachytherapy is a procedure that involves placing radioactive material(radium) inside the body(cervix).applicator selection depended on initial tumor and response rate to the external chemoradiation including tandem ovoid,tandem cylinder and tandem cylinder needle.if tandem ovoid did not covered sufficiently we used needle.We administrated dose of 85 to 90Gray to high risk clinical target volume and 70 to 75Gray to intermediate clinical target volume.
Category
Treatment - Other
2
Description
In control group We performed pelvic MRI for each patient to determine stage of cancer. Then according to three dimensional planing and physics calculation, study participants were treated with external chemoradiation (50 Gy in 20 fractions) with a linear accelerator. They also received weekly Cisplatin for 5 weeks.high dose rate brachytherapy by afterloading multi source device built by BEBIG company was given to patients over 3 weeks (1 session in each week).brachytherapy is a procedure that involves placing radioactive material(radium) inside the body(cervix).Applicator selection and insertion dose was selected based on response to external chemoradiation and baseline status of tumor including tandem ovoid,tandem cylinder and tandem cylinder needle.if tandem ovoid did not covered sufficiently we used needle. We administrated dose of 85 to 90Gray to high risk clinical target volume and 70 to 75Gray to intermediate clinical target volume.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Dr Mahdi Aghili
Street address
Imam Khomeini Hospital Complex , end of Keshavraz Boulevard,
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
No 206, First Floor, Official Building, Medical Faculty, Poursina Street, 16th Azar Street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 3685
Email
vcr@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
Iran University of Medical Sciences
Full name of responsible person
Maryam Garousi
Position
Assistant professor of Radiation oncology
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Department of Radiation oncology ,Iran University of Medical sciences,Hemat highway,Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2288 4548
Email
garousi.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Garousi
Position
Assistant Professor of radiation oncology
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
department of radio oncology،Iran University of medical sciences ,Hemat highway,Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2288 4548
Email
garousi.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam garousi
Position
Assistant professor of radiation oncology
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Department of Radiation oncology ,Iran university of Medical sciences , Hemat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2288 4548
Email
garousi.m@iums.ac.ir
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