The comparison of treatment outcomes between Hyperfractionated irradiation with and without concurrent chemotherapy in patients with locally advanced head and neck cancer
The comparison of treatment outcomes between hyperfractionated irradiation with and without concurrent chemotherapy in patients with locally advanced head and neck cancer
Design
The randomized clinical trial with paralled groups, double blinded witch conduct on 112 cancer patients who randomly divide through random block design
Settings and conduct
The radioncology clinic of Kerman university of medical sciences is the setting of research. The patients who refer for receiving treatment services divided to two groups, hyperfractionated irradiation with and without chemotherapy
Participants/Inclusion and exclusion criteria
1. pathology diagnosis of squamous cell carcinoma of the mucosa. (Non-cutaneous) 2. The patient's cancer is locally advanced 3. The age of patients is between 18 to 75 years . 4. Karnofsky Performance Score at least 60. 5. The patient should have no evidence of distant metastasis. 6. Not receiving previous radiation and chemotherapy 7. no previous surgery on the tumor 8. The patient should not be pregnant
Intervention groups
Intervention group: receiving hyperfractionated irradiation with low dose chemotherapy
control group: receiving hyperfractionated irradiation
Main outcome variables
The frequency of acute mucositis grade 3 and 4, neutropenia, neutropenic fever, nausea and vomiting, kidney and heart complications during intervention and also the survival rate after 18 months after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210404050835N1
Registration date:2021-07-10, 1400/04/19
Registration timing:prospective
Last update:2021-07-10, 1400/04/19
Update count:0
Registration date
2021-07-10, 1400/04/19
Registrant information
Name
ahmad sholevar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3325 7236
Email address
ahmad.sholevar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of treatment outcomes between Hyperfractionated irradiation with and without concurrent chemotherapy in patients with locally advanced head and neck cancer
Public title
Hyperfractionated irradiation with and without concurrent chemotherapy in locally advanced head and neck cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The response of the patient's cancer tissue sample is of squamous cell carcinoma of the mucosa (non-skin).
The patient's cancer is locally advanced.
The age of patients is at least 18 years and at most 75 years.
The Karnofsky Performance Score of the patient is at least 60.
The patient should have no evidence of distant metastasis.
Not receiving previous radiation therapy and chemotherapy
Failure to perform previous surgery on the tumor
The patient is not pregnant
Exclusion criteria:
The patient has synchronous primary lesion.
Patient with squamous cell carcinoma of the scalp and neck.
Presence of underlying diseases such as diabetes and hypertension, renal failure, ischemic heart disease.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, patients randomly divided to two groups based on random number sequence. The random number sequence create by SAS statistical software and patients randomly allocated to intervention and control groups according to their entrance order. The random allocation will conceal by opaque, sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
According to type of intervention, patients are not blind in this study, but data analyser and outcome assessor are blind. for data analysis, intervention and control groups are labeled with A and B and outcome assessor will follow up patients based on alphabetic list of names without name of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Vice-challenger of Treatment, Jomhori Eslami blvd.
City
Kerman
Province
Kerman
Postal code
7618747653
Approval date
2021-02-15, 1399/11/27
Ethics committee reference number
IR.KMU.AH.REC.1399.168
Health conditions studied
1
Description of health condition studied
locally advanced squamous cell carcinoma of head and neck
ICD-10 code
C76.0
ICD-10 code description
Malignant neoplasm of head, face and neck
Primary outcomes
1
Description
The frequency of acute mucositis grade 3 and 4
Timepoint
7, 14,21,28, 35, 42 and 49 days after intervention
Method of measurement
History and physical examination
2
Description
The frequency of neutropenia
Timepoint
7, 14,21,28, 35, 42 and 49 days after intervention
Method of measurement
History and physical examination
3
Description
The frequency of neutropenic fever
Timepoint
7, 14,21,28, 35, 42 and 49 days after intervention
Method of measurement
History and physical examination
4
Description
The frequency of nausea and vomiting
Timepoint
7, 14,21,28, 35, 42 and 49 days after intervention
Method of measurement
History and physical examination
5
Description
The frequency of renal complications
Timepoint
Before intervention, 7, 14,21,28, 35, 42 and 49 days after intervention
Method of measurement
History and physical examination
6
Description
The frequency of heart complications
Timepoint
Before intervention, 7, 14,21,28, 35, 42 and 49 days after intervention
Method of measurement
History and physical examination and electrocardiogram
Secondary outcomes
1
Description
The disease-free survival rate
Timepoint
18 months after intervention
Method of measurement
The telephone follow up
2
Description
The progression-free survival rate
Timepoint
18 months after intervention
Method of measurement
The telephone follow up
3
Description
The overall survival rate
Timepoint
18 months after intervention
Method of measurement
The telephone follow up
Intervention groups
1
Description
Intervention group: receiving hyperfractionated irradiation with low dose concurrent chemotherapy. Patients in this group treating by hyperfraction radiation therapy, with a total dose of 8160 cGy in 68 fractions, with a dose of 120 cGy perfraction twice daily, with an interval of at least six hours between each fractions(according to the technique and dose that used in the phase 3 RTOG9003 trial) five days per week by Linear accelerator radiation therapy machine, with concurrent chemotherapy of low-dose Intravenous Carboplatin(equivalent to 1.5 AUC) one day weekly, for total treatment duration of 7 weeks.
Category
Treatment - Other
2
Description
Control group: receiving hyperfractionated irradiation. Patients in this group treating by hyperfraction radiation therapy, with a total dose of 8160 cGy in 68 fractions, with a dose of 120 cGy perfraction twice daily, with an interval of at least six hours between each fractions(according to the technique and dose that used in the phase 3 RTOG9003 trial) five days per week by Linear accelerator radiation therapy machine, fot total treatment duration of 7 weeks.