Comparing the response and treatment complications of neoadjuvant chemo radiotherapy versus neoadjuvant radiotherapy in larger than 5 centimeter high grade soft tissue sarcoma of extremity between years 2018-2021
Comparing the pathological response to treatment between neoadjuvant chemoradiotherapy and radiotherapy alone. Comparing treatment-induced toxicities between neoadjuvant chemoradiotherapy and radiotherapy alone. Comparing local recurrence, distant metastasis, and post-op mortality, post-op complications rates between two groups. Comparing median overall survival and disease-free survival between two groups.
Design
Two arm parallel-group randomized trial with blinded data analysis and outcome assessment
Settings and conduct
This study is conducted in hospital settings. The participants are selected from the referring patients. After providing informed consent they are randomized into two intervention groups. The data is coded and then analyzed by a blinded analyst.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pathological diagnosis of soft tissue sarcoma in extremity; tumor size over 5 cm based on CT scan or MRI.
Exclusion criteria: not tolerating chemotherapy due to underlying renal, hepatic or cardiac problems or insufficient bone marrow reserve; recurrent or metastatic tumors; pregnancy or breastfeeding.
Intervention groups
Arm 1: 3D conformal radiotherapy with 46-50 Gy in 23-25 fractions concomitant with 3 cycles of chemotherapy including Epirubicin and Ifosfamide then surgery. Arm 2: 3D conformal radiotherapy with 46-50 Gy in 23-25 fractions without chemotherapy then surgery.
Main outcome variables
Pathological response to neoadjuvant treatments; treatment-induced toxicities; treatment tolerance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150929024266N4
Registration date:2019-11-24, 1398/09/03
Registration timing:prospective
Last update:2019-11-24, 1398/09/03
Update count:0
Registration date
2019-11-24, 1398/09/03
Registrant information
Name
Reza Ghalehtaki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2520
Email address
r-ghaletaki@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the response and treatment complications of neoadjuvant chemo radiotherapy versus neoadjuvant radiotherapy in larger than 5 centimeter high grade soft tissue sarcoma of extremity between years 2018-2021
Public title
Preop chemoradiotherapy for sarcoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pathological diagnosis of soft tissue sarcoma in extremity
Tumor size over 5 cm based on CT scan or MRI
Exclusion criteria:
Not tolerating chemotherapy due to underlying renal, hepatic or cardiac problems or insufficient bone marrow reserve
Recurrent o metastatic tumors
Pregnancy or breastfeeding
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
We opted for permuted block randomization for individuals by random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
We coded the data as each treatment group has a letter determining it so the data analyzer was blinded to the randomization. Others were not blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs- Tehran University of Medical Sciences
Street address
Vice-chancellor of research and technology, 6th floor, Central building of Tehran University of Medical Sciences, Ghods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.TUMS.VCR.REC.1397.1039
Health conditions studied
1
Description of health condition studied
Soft tissue sarcoma of the extremities
ICD-10 code
C49
ICD-10 code description
Malignant neoplasm of other connective and soft tissue
Primary outcomes
1
Description
Treatment-induced toxicities
Timepoint
Weekly during intervention, 4, 12 and 24 weeks after intervention
Method of measurement
Interviewing patient and physical examination including inspection and palpation, lab data and imaging
2
Description
Pathological response
Timepoint
After surgery
Method of measurement
Inspection of surgical specimen by the pathologist and defining the extent of tumor tissue necrosis
Secondary outcomes
1
Description
Post-op complications
Timepoint
4 weeks after surgery
Method of measurement
Interviewing and examining the patient
2
Description
Local recurrence
Timepoint
6,12 and 24 month after surgery
Method of measurement
Physical exam and imaging
3
Description
Distant metastasis
Timepoint
6,12 and 24 month after surgery
Method of measurement
Physical exam and imaging
Intervention groups
1
Description
Intervention group: 3DCRT 46-50Gy/23-25 fr plus Concurrent Chemotherapy with Epirubicin and Ifosfamide and then Surgical Resection
Category
Treatment - Other
2
Description
Control group: 3DCRT 46-50Gy/23-25 fr without Chemotherapy and then Surgical Resection
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer institute
Full name of responsible person
Ebrahim Esmati
Street address
Imam Khomeini Hospital Complex, Dr. Qarib Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2567
Email
eb_esmati@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Street address
No 206, First Floor, Official Building, Medical Faculty, Poursina Street, 16th Azar Street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8145 5618
Email
research@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
Reza Ghalehtaki
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Department of Radiation Oncology, Cancer Institute, Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2520
Fax
Email
rezaght@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Ghalehtaki
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2520
Fax
+98 21 6119 2520
Email
rezaght@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Ghalehtaki
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Department of Radiation Oncology, Cancer Institute, Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2520
Fax
Email
Rezaght@gmail.com
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
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The study protocol (complete), Informed consent (only the blank template), Clinical study report (as the published article)
When the data will become available and for how long
6 month after the end of the study
To whom data/document is available
Only to academic individuals.
Under which criteria data/document could be used
The written request is mandatory by email emphasizing the mentioning of study conductors in case of using data
From where data/document is obtainable
By contacting this email address: rezaght@gmail.com
What processes are involved for a request to access data/document
The study conductors will evaluate each request due to applicants' CV and scientific portfolio. The requests will be responded by 1 month after receiving an email.