The comparison of the preoperative radiotherapy with postoperative radiotherapy in patients with soft tissue sarcoma of the extremity referred to Firoozgar Hospital during 2017 to 2019
The comparison of the preoperative radiotherapy with postoperative radiotherapy in patients with soft tissue sarcoma of the extremity referred to Firoozgar Hospital during 2017 to 2019
Design
A non-randomized, unblinded, phase II clinical trial with a parallel group design of 80 patients, enrolled between July 2017 and September 2019.
Settings and conduct
In this randomized clinical trial, patients with proven diagnosis of localized soft tissue sarcoma of the extremity referring to orthopedic clinic of Firoozgar hospital in Tehran during 2017-2019 will be enrolled. Patients will be randomly divided into two equal groups (n = 40 in each group): 1- Preoperative Radiotherapy: Patients first will receive radiation therapy at a mean dose of 50 Gy between 4 and 6 weeks and then undergo limb preservation surgery. 2- Postoperative Radiotherapy: Patients first will undergo limb preservation surgery by an orthopedic surgeon and receive radiation therapy with 60-66 Gy after surgical wound healing. All patients will be evaluated during 1st, 6th and 12th months after treatment using a questionnaire for complications and limb function.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients with pathologically confirmed localized soft tissue sarcoma of the extremity; age ≥ 18 years; performance status < 2; Signing the informed consent form
Exclusion criteria include distant metastasis; pregnancy; history of connective tissue diseases
Intervention groups
1- Preoperative Radiotherapy Group: Patients first will receive radiation therapy at a dose of 50 Gy between 4 and 6 weeks and then undergo limb preservation surgery.
2- Postoperative Radiotherapy Group: Patients first will undergo limb preservation surgery by an orthopedic surgeon and receive radiation therapy with 60-66 Gy after surgical wound healing.
Main outcome variables
survival, recurrence and complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180919041070N3
Registration date:2020-01-12, 1398/10/22
Registration timing:registered_while_recruiting
Last update:2020-01-12, 1398/10/22
Update count:0
Registration date
2020-01-12, 1398/10/22
Registrant information
Name
Pedram Fadavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5522 8584
Email address
fadavi.p@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-18, 1398/09/27
Expected recruitment end date
2020-03-17, 1398/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the preoperative radiotherapy with postoperative radiotherapy in patients with soft tissue sarcoma of the extremity referred to Firoozgar Hospital during 2017 to 2019
Public title
Radiotherapy of soft tissue sarcoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pathologically confirmed localized soft tissue sarcoma of the extremity
Age ≥ 18 years
Performance status < 2
Exclusion criteria:
Distant metastasis
Pregnancy
History of connective tissue diseases
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Research Ethics Committee of Medical School of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-09-16, 1397/06/25
Ethics committee reference number
IR.IUMS.FMD.REC.1398.446
Health conditions studied
1
Description of health condition studied
Malignant neoplasm of connective and soft tissue
ICD-10 code
C49.9
ICD-10 code description
Malignant neoplasm of connective and soft tissue, unspecified
Primary outcomes
1
Description
Survival
Timepoint
12 months after treatment
Method of measurement
visiting the patient
2
Description
Recurrence
Timepoint
1, 6, and 12 months after treatment
Method of measurement
Taking history and physical exam
3
Description
Limb function
Timepoint
1, 6, and 12 months after treatment
Method of measurement
physical exam
Secondary outcomes
1
Description
Complications
Timepoint
1, 6, and 12 months after treatment
Method of measurement
Physical exam
Intervention groups
1
Description
Intervention group 1; Preoperative Radiotherapy: Patients first will receive radiation therapy at a mean dose of 50 Gy between 4 and 6 weeks and then undergo limb preservation surgery.
Category
Treatment - Other
2
Description
Intervention group 2; Postoperative Radiotherapy: Patients first will undergo limb preservation surgery by an orthopedic surgeon and receive radiation therapy with 60-66 Gy after surgical wound healing.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Pedram Fadavi
Street address
Firoozgar Hospital, Beh Afarin St, Valiasr Sq., District 6
City
Tehran
Province
Tehran
Postal code
15937-47811
Phone
+98 21 8214 1201
Fax
+98 21 8214 1201
Email
Fadavi.p@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malekoti
Street address
Fifth Floor, Central Headquarters, Iran University of Medical Sciences, Hemet Highway Between Chamran and Sheikh Fazlollah
City
Tehran
Province
Tehran
Postal code
14496-14535
Phone
+98 21 8670 2503
Fax
+98 21 8670 2703
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Hamideh Mahmoudi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Firoozgar Hospital, Beh Afarin St, Valiasr Sq., District 6
City
Tehran
Province
Tehran
Postal code
15937-47811
Phone
+98 21 8214 1201
Fax
+98 21 8214 1201
Email
research@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pedram Fadavi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Firoozgar Hospital, Beh Afarin St, Valiasr Sq., District 6
City
Tehran
Province
Tehran
Postal code
15937-47811
Phone
+98 21 8214 1201
Fax
+98 21 8214 1201
Email
Fadavi.p@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hamideh Mahmoudi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Firoozgar Hospital, Beh Afarin St, Valiasr Sq., District 6
City
Tehran
Province
Tehran
Postal code
15937-47811
Phone
+98 21 8214 1201
Fax
+98 21 8214 1201
Email
research@iums.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
Information about main outcomes of the study
When the data will become available and for how long
Six months after publishing the results
To whom data/document is available
Researchers in universities and scientific and research centers
Under which criteria data/document could be used
In order to improve the treatment of the disease and subsequent research and with the permission of the authors
From where data/document is obtainable
Department of radiation oncology of Iran university of medical sciences
What processes are involved for a request to access data/document
Sending the request in writing or by email to the authors