The comparison of acute toxicities and loading dose of drug in weekly and three - weekly Cisplatin delivered concomitant with radiotherapy in Squamous cell carcinoma of head and neck.
The goal of this trial is comparison between weekly and three - weekly Cisplatin delivered concomitant with radiotherapy.The Inclusion criteria is 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 and the Exclusion criteria is sever medical or psychiatric disorder; Patient who dose not have a good fallow up.All patients in this trial have a Squamous cell carcinoma of the head and neck.Sample size in weekly arm is 45 patients and in three- weekly arm is 45 patients too.In the first group Cisplatin dose is 40 mg/m2 once per week , and in second group 100mg/m2 every three weeks, is administered concomitant with radiotherapy.Hematologic, GI and Renal complications ,
Fever , Sensory neuropathy and Hypersensitivity reactions will be checked once per week in first arm and every three week in the second arm.Comparison of complications will be done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112225185N1
Registration date:2015-12-05, 1394/09/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-05, 1394/09/14
Registrant information
Name
Somaye Barihi
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3057
Email address
barihi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University Of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of acute toxicities and loading dose of drug in weekly and three - weekly Cisplatin delivered concomitant with radiotherapy in Squamous cell carcinoma of head and neck.
Public title
Complication assessment of chemotherapy with radiotherapy in 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 75 years old to 23 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Golestan, Ahvaz, Khozestan
City
Ahvaz
Postal code
Approval date
2015-03-10, 1393/12/19
Ethics committee reference number
ajums.REC.1393.382
Health conditions studied
1
Description of health condition studied
Head and neck tumor
ICD-10 code
C00
ICD-10 code description
Malignant neoplasm of lip
2
Description of health condition studied
Head and neck tumor
ICD-10 code
C01
ICD-10 code description
Malignant neoplasm of base of tongue
3
Description of health condition studied
Head and neck tumor
ICD-10 code
C03
ICD-10 code description
Malignant neoplasm of gum
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
C04
ICD-10 code description
Malignant neoplasm of floor of mouth
6
Description of health condition studied
Head and neck tumor
ICD-10 code
C05
ICD-10 code description
Malignant neoplasm of palate
7
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
8
Description of health condition studied
Head and neck tumor
ICD-10 code
C10
ICD-10 code description
Malignant neoplasm of oropharynx
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
Hematologic disorders
Timepoint
Befor start of treatment then weekly in first group and three weekly in second group
Method of measurement
CBC markers
2
Description
Neutropenic fever
Timepoint
Befor start of treatment then weekly in first group and three weekly in second group
Method of measurement
CBC markers and oral temperature
3
Description
Renal disorders
Timepoint
Befor start of treatment then weekly in first group and three weekly in second group
Method of measurement
Serum Cr
4
Description
GI disorders
Timepoint
Befor start of treatment then weekly in first group and three weekly in second group
Method of measurement
Clinical presentation of acute and chronic nausea and vomiting /oral mucositis/more than twice of normal range of liver enzymes
5
Description
Stopping the treatment
Timepoint
During treatment time
Method of measurement
With each complications
6
Description
Hypersensitivity reaction
Timepoint
Befor start of treatment then weekly in first group and three weekly in second group
Method of measurement
Clinical presentation
7
Description
Sensory neuropathy
Timepoint
Befor start of treatment then weekly in first group and three weekly in second group
Method of measurement
Clinical presentation of paresthesia in hands and feet
8
Description
Accumulative dose
Timepoint
End of treatment
Method of measurement
Accumulation of all drug doses during treatment
Secondary outcomes
1
Description
Stage of disease
Timepoint
Start of treatment
Method of measurement
TNM system
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 three- weekly with the dose of 100 mg/m2 concurrently with radiotherapy