Complication assessment of concurrent chemoradiotherapy with 100 mg/m2 continuous dose vs 100 mg/m2 divided into three consecutive days in patients with head and neck squamous cell carcinoma , A Randomized clinical trial
Complication assessment of concurrent chemoradiotherapy with 100 mg/m2 continuous dose vs 100 mg/m2 divided into three consecutive days in patients with head and neck squamous cell carcinoma
Design
A two-arm parallel groups randomized trial randomized phase 2-3 by permuted block in 70 patients
Settings and conduct
This study enrolled men and women with head and neck SCC under 70 years of age. Patients underwent concurrent chemoradiation with cisplatin at Imam Khomeini Hospital Cancer Institute between 2019 and 2021. Patients with impaired Kidney functions and diabetes were excluded. Patients randomly divided into two groups after filling informed consent. Basic audiometry were checked before start of the treatment schedule. Patients received 100 mg/m2 daily continuous dose every three weeks in group A. Group B, received 100 mg / m2 cisplatin divided into three consecutive days every three weeks. Patients were pre-hydrated and post-hydrated with 2 liters of normal saline. CBC DIFF, BUN, CR tests were checked in all patients before and after chemotherapy were rechecked until normalization or the patient excluded from the study when necessary. During radiotherapy, mucositis, dysphagia, nausea, vomiting, weight loss, and tests were checked and recorded weekly. Complications were classified according to the CTCAE V.4 system.
Participants/Inclusion and exclusion criteria
Patients under 70 years of age, known case of head and neck SCC with performance status >= 70%
Definitive or adjuvant chemoradiation/ extranodal extension or positive margin
Radiation dose 66-70 Gy
Exclusion criteria:
1. Distant metastasis
2. Receiving previous cytotoxic drug
3. kidney disease and diabetes
4. Intolerance to cisplatin
Intervention groups
Interventional group: cisplatin divided into 3 consecutive
Control group: cisplatin in 24 hours continuously
Main outcome variables
Mucositis, Dysphasia, Cytopenia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201220049776N1
Registration date:2023-05-27, 1402/03/06
Registration timing:retrospective
Last update:2023-05-27, 1402/03/06
Update count:0
Registration date
2023-05-27, 1402/03/06
Registrant information
Name
Arefeh Saeedian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2611 6394
Email address
a-saeedian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-11, 1398/09/20
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
2019-11-22, 1398/09/01
Actual recruitment end date
2021-09-23, 1400/07/01
Trial completion date
2021-09-23, 1400/07/01
Scientific title
Complication assessment of concurrent chemoradiotherapy with 100 mg/m2 continuous dose vs 100 mg/m2 divided into three consecutive days in patients with head and neck squamous cell carcinoma , A Randomized clinical trial
Public title
Comparison of 3-weekly administration of continuous dose cisplatin with divided dose in head and neck carcinoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women under 70 years of age, known case of head and neck SCC with karnofsky performance status >= 70%
Definitive chemoradiation or adjuvant chemoradiation in patients with extranodal extension or positive margin
Radiation dose 66-70 Gy
Exclusion criteria:
History of chemotherapy
Kidney disease and Diabetes
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization 60 participants was planned by 15 random blocks of 4, each including two interventions and two controls via online system (http://sealedenvelope.com). In order to apply concealment, unique codes was produced by the online system. Physicians knew the codes and after enrollment the participants allocated group become visible to patients and physicians by the physician's secretory.
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
National Ethics Committee in Biomedical Research
Street address
Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor, Vice Chancellor for Research and Technology
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2019-12-02, 1398/09/11
Ethics committee reference number
IR.TUMS.IKHC.REC.1398.220
Health conditions studied
1
Description of health condition studied
Malignant neoplasm of base of tongue
ICD-10 code
C01
ICD-10 code description
Malignant neoplasm of base of tongue
2
Description of health condition studied
Malignant neoplasm of other and unspecified parts of tongue
ICD-10 code
C02
ICD-10 code description
Malignant neoplasm of other and unspecified parts of tongue
3
Description of health condition studied
Malignant neoplasm of oropharynx
ICD-10 code
C10
ICD-10 code description
Malignant neoplasm of oropharynx
4
Description of health condition studied
Malignant neoplasm of nasopharynx
ICD-10 code
C11
ICD-10 code description
Malignant neoplasm of nasopharynx
5
Description of health condition studied
Malignant neoplasm of hypopharynx
ICD-10 code
C13
ICD-10 code description
Malignant neoplasm of hypopharynx
6
Description of health condition studied
Malignant neoplasm of pyriform sinus
ICD-10 code
C12
ICD-10 code description
Malignant neoplasm of pyriform sinus
7
Description of health condition studied
Malignant neoplasm of larynx
ICD-10 code
C32
ICD-10 code description
Malignant neoplasm of larynx
Primary outcomes
1
Description
Mucositis
Timepoint
Weekly during radiation for 7 weeks
Method of measurement
Examination
2
Description
Disphasia
Timepoint
Weekly during radiation for 7 weeks
Method of measurement
Examination
3
Description
Cytopenia
Timepoint
Weekly during radiation for 7 weeks
Method of measurement
Laboratory data
Secondary outcomes
1
Description
Disease free survival
Timepoint
18 months
Method of measurement
Phone calls. Visit at the Office
2
Description
Overall survival
Timepoint
18 months
Method of measurement
Phone calls. Visit at the Office
Intervention groups
1
Description
Intervention group:In this group, they received cisplatin every 21 days at a dose of 100 mg per cubic meter divided into three consecutive days. Chemotherapy courses were between 2 and 3 courses during the course of radiation therapy.
Category
Treatment - Drugs
2
Description
Control group: In this group, they received cisplatin every 21 days at a dose of 100 mg per cubic meter continuously in 24 hours. Chemotherapy courses were between 2 and 3 courses during the course.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini Hospital
Full name of responsible person
Arefeh Saeedian
Street address
Keshavarz Boulevard, Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2587
Email
Imamhospital@tums.ac.ir
Web page address
http://ikhc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Marzieh Lashkari
Street address
Ground floor: Building No. 4, Poursina St. (north side of Tehran University), Ghods St
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3102
Email
itcenter@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
Arefeh Saeedian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Tehran, at the end of Keshavarz Boulevard, Dr. Gharib Street. Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2587
Email
a-saeedian@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Aghili
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Tehran, at the end of Keshavarz Boulevard, Dr. Gharib Street;Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2587
Email
aghili@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arefeh Saeedian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Keshavarz Boulevard, Dr. Gharib Street; Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2587
Email
a-saeedian@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Not applicable
Title and more details about the data/document
The datasets used and analyzed during the current study are available from the corresponding (Dr Arefefeh Saeedian) upon reasonable request by two weeks.
When the data will become available and for how long
The dataset files will become available starting 6 months after publication.
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
Documents will be shared for systematic reviews only
From where data/document is obtainable
Dr Arefeh Saeedian
Radiation Oncologist
a-saeedian@razi.tums.ac.ir
What processes are involved for a request to access data/document
The datasets used and analyzed during the current study are available from the corresponding (Dr Arefefeh Saeedian) upon reasonable request by two weeks.