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Evaluation of addition of concurrent Capecitabine to brachytherapy in patients with advanced cervical cancer

Protocol summary

Study aim
Evaluating the effect of capecitapine use during brachytherapy on improving local control and survival in advanced cervical cancer
Design
A phase II, two arm, non- randomized clinical trial, including an intervention and a control group. The intervention group includes 35 patients, recruited during the alloted period, from patients referred for definitive chemoradiotherapy. Comparison is done at the end of one year of follow up, ‌in terms of no of recurrent cases and side effects of intervention with control group, chosen either from previously treated patients, or patients not willing to enter trial, and matched based on stage, comorbidities and response to external chemoradiotherapy.
Settings and conduct
Patient recruitment will happen in three centers, two university hospitals (Omid and Emam Reza hospitals) and a charity hospital (Reza Radiotherapy Oncology Center). All patients will be referred for Brachytherapy to Reza Radiotherapy Oncology Center after the standard external chemoradiotheapy. Patients in the study group are put on concurrent capecitabine at the time of brachytherapy treatment
Participants/Inclusion and exclusion criteria
Inclusion criteria: definite diagnosis of cervical cancer on pathology sample, histology of SCC or adenocarcinoma, stage IB-IVA, adequate performance status Exclusion criteria : patient's reluctance to participate in the trial, uncontrolled comorbidities, eg Diabetes and Hypertension, and Warfarin use.
Intervention groups
Intervention group includes advanced cervical cancer patients who are put on oral capecitabine 825 milligram per meter square body surface area twice daily for 10 to14 days during brachytherapy Control group includes advanced cervical cancer patients who have been treated with standard treatment, that is brachytherapy is done without chemotherapy
Main outcome variables
adverse effects, overall survival and disease free survival

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210306050600N1
Registration date: 2021-03-26, 1400/01/06
Registration timing: prospective

Last update: 2021-03-26, 1400/01/06
Update count: 0
Registration date
2021-03-26, 1400/01/06
Registrant information
Name
soudeh arastouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 6082
Email address
arastoueis971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-30, 1400/01/10
Expected recruitment end date
2022-03-30, 1401/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of addition of concurrent Capecitabine to brachytherapy in patients with advanced cervical cancer
Public title
Brachytherapy with concurrent Capecitabine in advanced cervical cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
definite diagnosis of cervical cancer in the pathological sample histology of SCC or Adenocarcinoma stage IB-IVA based on gynecologic examination and imaging, making these patients chemoradiotherapy candidates no evidence of distant metastasis adequate performance status ( ECOG ≥2)
Exclusion criteria:
not willing to enter the trial uncontrolled comorbidities, like diabetes mellitus and hypertension warfarin use
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Patient who are recruited into the trial, will be placed in the intervention arm. Control group will be matched patients who have not received concomitant chemotherapy with brachytherapy, either have not entered the trial or those previously treated.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashad University of medical Sciences
Street address
Daneshgah Avenue
City
Mashad
Province
Razavi Khorasan
Postal code
9176613775
Approval date
2021-02-28, 1399/12/10
Ethics committee reference number
IR.MUMS.MEDICAL. REC.1399. 765

Health conditions studied

1

Description of health condition studied
Cervical cancer, FIGO stage IB-IVA
ICD-10 code
C53
ICD-10 code description
Malignant neoplasm of cervix uteri

Primary outcomes

1

Description
disease free survival
Timepoint
every 3 months after intervention for 12 months
Method of measurement
Using patients' registries, which are the result of patient's follow up visits every three months after completion of treatment to the treating doctor. Recurrence could be proved using biopsy or imaging.

2

Description
Acute Gastrointestinal side effects: nausea and vomiting
Timepoint
During each brachytherapy session. which happens every second or third day
Method of measurement
By history taking, and the severity of this side effect will be recorded based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

3

Description
Acute hematologic side effects: Anemia
Timepoint
during every brachytherapy session which is done every second or third day or weeky during intervention
Method of measurement
By history taking, and looking for signs of cytopenias, like bruises, fever, weakness and mucositis. In case of suggesting history, Complete blood count is requested, otherwise a routine Complete blood count is done weekly

4

Description
Acute hematologic side effects: leucopenia
Timepoint
During every brachytherapy session which is done every second or third day or weeky during intervention
Method of measurement
By history taking, and looking for signs of leukopenia, like fever and mucositis. In case of suggesting history, Complete blood count is requested, otherwise a routine Complete blood count is done weekly

5

Description
Acute gastrointestinal side effects: diarrhoea
Timepoint
During each brachytherapy session, which happens every second or third day
Method of measurement
By history taking, and the severity of this side effect will be recorded based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

6

Description
Hand foot syndrome
Timepoint
During each brachytherapy session, which happens every second or third day
Method of measurement
By physical examination, and the severity of this side effect will be recorded based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Secondary outcomes

1

Description
Overall survival( survival from the time of diagnosis till death)
Timepoint
every 3 months after the intervention
Method of measurement
Results of 12 months of follow up of patients regarding overall survival will be recorded using patient's records or in case of lack of adherence to follow up, through phone call

2

Description
Acute hematologic side effect: Thrombocytopenia
Timepoint
Every brachytherapy session, which happens every second or third day
Method of measurement
By history taking, asking for any bleeding or bruises, in case of positive history a complete blood count is requested. In case of negative history, a complete blood count is routinely done weekly during brachytherapy treatment, which takes ten to fourteen days,

Intervention groups

1

Description
Intervention group: patients who are eligible to enter the trial, are put on Capecitabine 825mg/m2 twice daily during their brachytherapy treatment, starting from the first fraction of their brachytherapy treatment till the last fraction, which can take between 10-14 days. Capecitabine is an oral chemotherapy drug, which can also increase the sensitivity of cells to radiation. In this study, capecitabine-ACTE will be used.
Category
Treatment - Drugs

2

Description
Control group: patients who have received the current standard treatment, that is brachytherapy done without concurrent chemotherapy, are compared with intervention group after they are matched based on variables like stage of disease, comorbidities and performance status. This group can be chosen from the patients who have not entered the trial, or patients who have received the standard treatment in the past.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Soudeh Arastouei
Street address
Omid hospital, Alandasht square, Kooh-Sangi Avenue,
City
Mashad
Province
Razavi Khorasan
Postal code
٩١٧۶۶١٣٧٧۵
Phone
+98 51 3842 6082
Fax
+98 51 3842 8622
Email
omidhos@mums.ac.ir
Web page address
https://omid.mums.ac.ir/

2

Recruitment center
Name of recruitment center
Reza Radiotherapy and oncology center
Full name of responsible person
Fatemeh Homaei Shandiz
Street address
19th Rafsanjani, 7th Azar square, Shahrak Gharb
City
Mashad
Province
Razavi Khorasan
Postal code
9184166759
Phone
+98 51 3500 8715
Email
info@rroc.ir

3

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Soudeh Arastouei
Street address
Emam Reza hospital, Emam reza hospital square, Ebn-e-Sina Avenue
City
Mashad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Avenue
City
Mashad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Soudeh Arastouei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Omid Hospital, Alandasht square, Kooh-Sangi Avenue
City
Mashad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6082
Email
arastoueis971@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Homaei Shandiz
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Omid hospital, Alandasht square, Kooh-Sangi Avenue
City
Mashad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6082
Email
HomaeeF@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Soudeh Arastouei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Omid Hospital, Alandasht square, Kooh-Sangi avenue
City
Mashad
Province
Razavi Khorasan
Postal code
9176613775
Phone
0099 51 38426082
Email
arastoueis971@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
De-identified demographic information and data about the primary outcome measures will be shared
When the data will become available and for how long
starting 6 months after the publication
To whom data/document is available
data will only be available to people working in academic institutions
Under which criteria data/document could be used
data will only be available for research oriented prurposes
From where data/document is obtainable
In order to access the data, applicant should send an email requesting access, to Dr Soudeh Arastouei(arastoueis971@mums.ac.ir)
What processes are involved for a request to access data/document
After receiving the email, communication will be done with the ethic committee of Mashad university of medical sciences for further authorization
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