The goal of this trial is to compare radiologic response rate between weekly and triweekly Cisplatin delivered concomitant with radiotherapy.The Inclusion criteria is histopathologically confirmed Squamous cell carcinoma ; age 18- 70 years ; ECOG performance status of 0-1; No distant metastasis; WBC equal to more than 4000; PLT equal to more than 100000; Hb equal to more than 10; Serum Cr less than 1.5 ; Serum aminotransferase less than twice of normal range and the Exclusion criteria is sever medical or psychiatric disorder; Patient who dose not have a good fallow up.No operation was done for patients before enrolling in the trial.Sample size in weekly arm in nasopharyngeal carcinoma is 7 patients and in nonnasopharyngeal is 24 patients.In triweekly arm in nasopharyngeal carcinema, the sample size is 11 patients and in non-nasopharyngeal is 21 patients .in the first group Cisplatin dose is 40 mg/m2 once per week , and in second group 100mg/m2 every three weeks, which is administered concomitant with radiotherapy.the comparison between radiologic response rate in two groups will be done after 8-10 weeks of radiotherapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041125211N1
Registration date:2016-04-11, 1395/01/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-11, 1395/01/23
Registrant information
Name
Maedeh Barahman
Name of organization / entity
Ahvaz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3057
Email address
berahman.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University Of Medical Sciences
Expected recruitment start date
2014-08-06, 1393/05/15
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Radiologic response rate of chemoradiotherapy in inoperable head and neck squamous cell carcinoma; weekly versus triweekly cisplatin schedule
Public title
Radiologic response rate of chemotherapy with radiotherapy in previously inoperable head and neck tumors
Purpose
Treatment
Inclusion/Exclusion criteria
(Inclusion criteria: Pathologic report of Squamous.cell.carcinoma ; Age 18- 70 years ; ECOG performance status of 0-1; No distant metastasis; WBC equal to more than 4000; PLT equal to more than 100000; Hb equal to more than 10; Serum Cr less than 1.5 ; Serum aminotransferase less than twice of normal range.) (Exclusion criteria: Sever medical or psychiatric disorder; Patient who dose not have a good fallow up.)
Age
From 23 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
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
Ahvaz University Of Medical Sciences
Street address
Radiotherapy Ward, Golestan Hospital,
City
Ahvaz
Postal code
Approval date
2014-12-27, 1393/10/06
Ethics committee reference number
ajums.REC.1393.383
Health conditions studied
1
Description of health condition studied
Head and neck tumor
ICD-10 code
C10
ICD-10 code description
Malignant neoplasm of oropharynx
2
Description of health condition studied
Head and neck tumor
ICD-10 code
C05
ICD-10 code description
Malignant neoplasm of palate
3
Description of health condition studied
Head and neck tumor
ICD-10 code
C04
ICD-10 code description
Malignant neoplasm of floor of mouth
4
Description of health condition studied
Head and neck tumor
ICD-10 code
C02
ICD-10 code description
Malignant neoplasm of other and unspecified parts of tongue
5
Description of health condition studied
Head and neck tumor
ICD-10 code
C06
ICD-10 code description
Malignant neoplasm of other and unspecified parts of mouth
6
Description of health condition studied
Head and neck tumor
ICD-10 code
C03
ICD-10 code description
Malignant neoplasm of gum
7
Description of health condition studied
Head and neck tumor
ICD-10 code
C00
ICD-10 code description
Malignant neoplasm of lip
8
Description of health condition studied
Head and neck tumor
ICD-10 code
C01
ICD-10 code description
Malignant neoplasm of base of tongue
9
Description of health condition studied
Head and neck tumor
ICD-10 code
C11
ICD-10 code description
Malignant neoplasm of nasopharynx
10
Description of health condition studied
Head and neck tumor
ICD-10 code
C12
ICD-10 code description
Malignant neoplasm of piriform sinus
11
Description of health condition studied
Head and neck tumor
ICD-10 code
C13
ICD-10 code description
Malignant neoplasm of hypopharynx
12
Description of health condition studied
Head and neck tumor
ICD-10 code
C14
ICD-10 code description
Malignant neoplasm of other and ill-defined sites in the lip,oral cavity and pharynx
Primary outcomes
1
Description
Radiologic respons rate
Timepoint
Before start of treatment and after 8-10 week of radiotherapy
Method of measurement
CTscan
Secondary outcomes
1
Description
Stage of disease
Timepoint
Start of treatment
Method of measurement
TNM system
2
Description
Tumor differentiation
Timepoint
Start of treatment
Method of measurement
Patologic report
Intervention groups
1
Description
In the first group IV Cisplatin will be administered with the dose of 40 mg/ m2 once weekly concurrently with radiotherapy
Category
Treatment - Drugs
2
Description
In the second group IV Cisplatin will be administered triweekly with the dose of 100 mg/m2 concurrently with radiotherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz, Golestan Hospital, Radiotherapy Ward
Full name of responsible person
Dr.maedeh Berahman Assistant Of Radiation Oncology