comparison of acute hematologic and renal toxicities in two schedules of weekly and three weekly cisplatin in chemoradiation of epithelial carcinoma of head and neck
Design
This is a Phase 2 clinical trial
The sample size was calculated based on the difference in leukopenia between the two groups. According to previous studies, 50 subjects in each group were calculated.
Patients are stratified based on age, primary location of the disease, intent of treatment(adjuvant or definitive) and prior induction chemotherapy, and then using permuted block random method technique, they were randomized in two weekly 40mg/m2 and three weekly 100mg/m2 cisplatin arms
Settings and conduct
The study was conducted among head and neck patients referred to the oncology department of Imam Hossein Hospital
Participants/Inclusion and exclusion criteria
epithelial carcinoma of head and neck that are candidate for concurrent chemoradiation
stage 3,4 of the disease
aged 20-75 years old
ECOG performance status 0-2
no prior radiation therapy and chemotherapy
normal organs function
no active multiple primary cancers
no uncontrolled comorbidities
Intervention groups
The control group consisted of patients treated with a regimen of cisplatin 100mg / m2 every three weeks
The intervention group included patients treated with 40 mg / m2 of cisplatin weekly
Main outcome variables
changes in leukocyte, neutrophil, lymphocyte, hemoglobin, platelet
treatment compliance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180223038829N1
Registration date:2018-03-12, 1396/12/21
Registration timing:retrospective
Last update:2018-03-12, 1396/12/21
Update count:0
Registration date
2018-03-12, 1396/12/21
Registrant information
Name
Shokoufe Norouzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8842 6899
Email address
shokoufe.norouzi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
2016-03-20, 1395/01/01
Actual recruitment end date
2017-11-22, 1396/09/01
Trial completion date
empty
Scientific title
Comparison of acute hematologic and renal toxicities in two chemotherapy schedules of cisplatin for epithelial cell carcinoma of head and neck
Public title
Comparison of two protocol chemotherapy for cisplatin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
histologically proven malignancy in resected specimen
all epithelial carcinoma of head and neck that needs concurrent chemoraradiation
stages 3,4 of the disease
aged 20-75 years old
ECOG Performance Status :0-2
no prior radiation therapy or chemotherapy
adequate organ function
written informed consent
Exclusion criteria:
active multiple primary cancers; synchronous or metachronous within 5 years
infection requiring systemic treatment
women who are or may be pregnant
psychosis or psychiatric symptoms/signs that judged to male participation in the study difficult
uncontrolled diabetes mellitus
uncontrolled hypertension
Age
From 20 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
77
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization
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
Ethics committee of shahid Beheshti University of Medical Sciences
Street address
Next to Taleghani Hospital, Yemeni Ave, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2016-07-19, 1395/04/29
Ethics committee reference number
IR.SBMU.MSP.REC.1395.161
Health conditions studied
1
Description of health condition studied
epithelial carcinoma of head and neck
ICD-10 code
C00-C14
ICD-10 code description
Malignant neoplasms of lip, oral cavity and pharynx
Primary outcomes
1
Description
leukocyte
Timepoint
weekly
Method of measurement
blood serum level
2
Description
lymphocyte
Timepoint
weekly
Method of measurement
blood serum level
3
Description
neutrophil
Timepoint
weekly
Method of measurement
blood serum level
4
Description
hemoglobin
Timepoint
weekly
Method of measurement
blood serum level
5
Description
platelet
Timepoint
weekly
Method of measurement
blood serum level
6
Description
creatinin
Timepoint
weekly
Method of measurement
blood serum level
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: weekly schedules of cisplatin
Category
Treatment - Drugs
2
Description
Control group: three weekly schedule of cisplatin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein Hospital
Full name of responsible person
shokoufe Norouzi
Street address
No 10, Far Alley, Farhang Alley, Hamid Alley, Dr.Shariati Ave, Tehran Town
City
Tehran
Province
Tehran
Postal code
1639643413
Phone
+98 21 8842 6899
Email
shokoufe.norouzi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Emam Hossein Hospital, Shahis Madani Ave
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 2475
Email
shokoufe.norouzi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
shokoufe Norouzi
Position
Resident of radiation oncology
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
No 10, Far Alley, Farhang Alley, Hamid Alley, Dr.Shariati Ave, Tehran Town
City
Tehran
Province
Tehran
Postal code
1639643413
Phone
+98 21 8842 6899
Email
shokoufe.norouzi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
shokoufe Norouzi
Position
Resident of radiation oncology
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
No 10, Far Alley, Farhang Alley, Hamid Alley, Dr.Shariati Ave, Tehran Town
City
Tehran
Province
Tehran
Postal code
1639643413
Phone
+98 21 8842 6899
Email
shokoufe.norouzi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
shokoufe Norouzi
Position
Resident of radiation oncology
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
No 10, Far Alley, Farhang Alley, Hamid Alley, Dr.Shariati Ave, Tehran Town
City
Tehran
Province
Tehran
Postal code
1639643413
Phone
+98 21 8842 6899
Email
shokoufe.norouzi@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available