Determining the frequency of complete clinical response and discontinuation of treatment due to acute complications in patients with laryngeal cancer undergoing hypofractionated radiotherapy.
Determining the frequency and severity of dermatitis in patients with laryngeal cancer undergoing hypofractionated radiotherapy.
Determining the frequency and severity of esophagitis and voice quality in patients with laryngeal cancer undergoing hypofractionated radiotherapy.
Design
In this phase 2 clinical trial, there is a study group. The sample size is 49 people. Eligible people are selected consecutively from among people with early-stage laryngeal cancer.
Settings and conduct
This phase two clinical trial is conducted on patients with early-stage laryngeal cancer who are referred to the radiotherapy oncology department of Namazi Hospital affiliated to Shiraz University of Medical Sciences. The estimated time for conducting the study will be 1402-1403. All patients receive hypofractionated radiotherapy with a total dose of 54 Gy in 18 sessions (3 Gy per session)
Participants/Inclusion and exclusion criteria
Inclusion crietria:1.Definitive diagnosis of squamouse cell carcinoma of larynx based on pathology report 2. glottic lesionsT1-2 3.No involvement of neck lymph nodes 4. 18 to 75 years old 5.Performance level based on ECOG, less than 3 Exclusion critria:1.Other malignant histologies of the larynx except scc 2.History of head and neck radiotherapy 3. Previous history of chemotherapy 4. History of diabetes or uncontrolled blood pressure 5. History of tracheostomy 6. History of laser microsurgery
Intervention groups
In the clinical trial, there is one study group in which patients with early-stage laryngeal cancer are treated with hypofractionated radiotherapy (18 sessions, 3 Gy per session)
Main outcome variables
Pathologic complete response؛ side effects
General information
Reason for update
Acronym
non
IRCT registration information
IRCT registration number:IRCT20230128057262N1
Registration date:2023-07-21, 1402/04/30
Registration timing:registered_while_recruiting
Last update:2023-07-21, 1402/04/30
Update count:0
Registration date
2023-07-21, 1402/04/30
Registrant information
Name
Mahsa Elahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3632 4781
Email address
elahi.mahsa1992@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-19, 1402/04/28
Expected recruitment end date
2024-07-18, 1403/04/28
Actual recruitment start date
2022-07-19, 1401/04/28
Actual recruitment end date
2024-07-18, 1403/04/28
Trial completion date
2025-02-20, 1403/12/02
Scientific title
To evaluate the feasibility and safety of hypofractionated radiotherapy in early laryngeal cancers: a phase 2 clinical trial
Public title
Hypofractionated radiotherapy in early laryngeal cancers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of squamous cell carcinoma of the larynx based on pathology report
Glottic lesions T1-2
No involvement of neck lymph nodes (N0)
18 to 75 years old
Performance level based on ECOG less than 3
Exclusion criteria:
Other malignant histologies of the larynx except squamous cell carcinoma
History of head and neck radiotherapy
Previous history of chemotherapy
Previous history of malignancy except skin BCC
History of diabetes or uncontrolled blood pressure
History of tracheostomy
With a history of laser microsurgery
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:
49
Actual sample size reached:
49
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
nothing
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Faculty of medicine, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71937-11351
Approval date
2023-02-21, 1401/12/02
Ethics committee reference number
IR.sums.med.rec.1401.495
Health conditions studied
1
Description of health condition studied
laryngeal cancer
ICD-10 code
C32
ICD-10 code description
Malignant neoplasm of larynx
Primary outcomes
1
Description
Pathologic complete response
Timepoint
Post operation
Method of measurement
Pathologic examination
Secondary outcomes
1
Description
Side effects
Timepoint
Weekly during intervention course
Method of measurement
Radition therapy toxicity critria
Intervention groups
1
Description
Intervention group: Patients with early stage laryngeal cancer are treated with hypofractionated radiotherapy with a total dose of 54 Gy in 18 sessions.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Mohammad Mohammadianpanah
Street address
Thirty-Sixth room, Department of radiation oncology, Namazi hospital, Namazi square
City
shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
mohpanah@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammadhashem Hashempur
Street address
Deputy of research, Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3235 7282
Email
hashempurm@sums.ac.ir
Web page address
http://research.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mahsa Elahi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
N0. 2
City
Shiraz
Province
Fars
Postal code
71859-39799
Phone
+98 71 3632 4781
Fax
+98 917 154 1669
Email
elahi.mahsa1992@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Mohammadianpanah
Position
Full Proffosor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Thiry-six room,Department of radiation oncology,Namazi hospital,Namazi square
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4320
Email
elahi.mahsa1992@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahsa Elahi
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Forty- seccond room,Department of radiation oncology,Namazi hospital,Namazi square
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
elahi.mahsa1992@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
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 treatment of disease and subsequent research and with the permission of the authors
From where data/document is obtainable
Department of radiation oncology of Shiraz university of medical science
What processes are involved for a request to access data/document
Sending the request in writing or by email to authors