Understanding Compliance, disease control, Survival Rates and Complications in Patients following Hypofractionated Postoperative Radiation Therapy (HYPORT) for Head and Neck Squamous Cell Carcinoma instead of conventional treatment
Shortening the overall radiationtherapy(RT) treatment time has advantages in cost and treatment burden, but data on hypofractionated RT in head and neck squamous cell carcinoma are limited. This study assessed the safety of moderately hypofractionated RTin the postoperative setting
Design
This clinical trial study comparing a hypofractionation group and a group with conventional treatment during the years 1403 to 1405 is carried out in the Radio Oncology Department of the Cancer Institute affiliated to Tehran University of Medical Sciences. Patients with a pathologically proven stage I-IVB squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx after surgery with pathology showing one or more intermediate risk factors are eligible.
Phase 2 was used on 60 patients with control with non-randomized parallel groups
Settings and conduct
This clinical trial study comparing a hypofractionation group and a group with conventional treatment during the years 1403 to 1405 is carried out in the Radio Oncology Department of the Cancer Institute affiliated to Tehran University of Medical Sciences. Patients with a pathologically proven stage I-IVB squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx after surgery with pathology showing one or more intermediate risk factors are eligible.
Participants/Inclusion and exclusion criteria
T3/T4
Close margin <5mm
Positive LVI/PNI
Positive lynph node
Intervention groups
Hypofractional versus conventional
Main outcome variables
Determining treatment tolerance (completion of treatment within 3 weeks) in HNSCC patients undergoing hypofractionated radiotherapy after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240831062918N1
Registration date:2024-09-14, 1403/06/24
Registration timing:registered_while_recruiting
Last update:2024-09-14, 1403/06/24
Update count:0
Registration date
2024-09-14, 1403/06/24
Registrant information
Name
Elham Mansourabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8825 0625
Email address
elham.mansourabadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-26, 1403/06/05
Expected recruitment end date
2026-08-27, 1405/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Understanding Compliance, disease control, Survival Rates and Complications in Patients following Hypofractionated Postoperative Radiation Therapy (HYPORT) for Head and Neck Squamous Cell Carcinoma instead of conventional treatment
Public title
Hypofractionated Radiation Therapy (HYPORT) for Head and Neck Squamous Cell Carcinoma
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
T3/T4
Close margin <5mm
Positive LVI/PNI
Positive lynph node
Exclusion criteria:
Past radiation Thrapy
Metastatic disease
feeding tube dependent
positive margine
ENE
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Imam Khomeini Hospital Cancer Institute
City
tehran
Province
Tehran
Postal code
5555555555
Approval date
2024-08-26, 1403/06/05
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.222
Health conditions studied
1
Description of health condition studied
HEAD AND NECK SCC
ICD-10 code
C00-D48
ICD-10 code description
HEAD AND NECK SCC
Primary outcomes
1
Description
Treatment tolerance
Timepoint
Determination of LC, DFS and OS for 2,3 and 5 years
Method of measurement
OBSERVATION
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: hypofraction : 46.5 GY/ 15F. IN 5 DAYS/WEEK (3.1 GY per Fraction)
Category
Treatment - Devices
2
Description
Control group: Conventional : 70gy / 35F, with 5Days/Week, (2GY per Fraction)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Cancer Institute
Full name of responsible person
Reza Ghaletaki
Street address
Imam Khomeini Hospital Cancer Institute
City
Tehran
Province
Tehran
Postal code
5555555555
Phone
+98 21 6119 2585
Email
elham.mansourabadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza GhaleTaki
Street address
Imam Khomeini Hospital Cancer Institute
City
teran
Province
Tehran
Postal code
5555555555
Phone
+98 21 6119 2585
Email
elham.mansourabadi@gmail.com
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 Ghaletaki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Imam Khomeini Hospital Cancer Institute
City
tehran
Province
Tehran
Postal code
5555555555
Phone
+98 21 6119 2585
Email
rezaght@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Ghaletaki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Imam Khomeini Hospital Cancer Institute
City
tehran
Province
Tehran
Postal code
5555555555
Phone
+98 21 6119 2585
Email
rezaght@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Mansourabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Imam Khomeini Hospital Cancer Institute
City
tehran
Province
Tehran
Postal code
5555555555
Phone
+98 21 6119 2585
Email
elham.mansourabadi@gmail.com
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
Part of data
When the data will become available and for how long
3 years
from 1406
To whom data/document is available
every body
Under which criteria data/document could be used
No Limitation
From where data/document is obtainable
Imam Khomeini Hospital Cancer Institute
What processes are involved for a request to access data/document