Aim: The aim of this trial is to evaluate OS, PFS and toxicity of R-CHOP-14 compared to R-CHOP-21 in untreated stage III and IV B-cell NHL patients with Iranian ethnicity. Inclusion criteria: Age; sex; type of NHL; subtype; Ki-67 index; organomegaly; lymphadenopathy; radiotherapy; anatomic sites of NHL; recurrence.
Exclusion criteria: cardiovascular; renal; hepatic disease (hepatitis B or hepatitis C; T-cell lymphoma;patients with initial neutrophil count <1.5×109 per L; initial platelet count <100×109 per L.
Population, volume and time: patients with previously untreated stage III and IV indolent and aggressive B-cell NHL were randomly assigned by using a minimization method to receive six to eight cycles of either R-CHOP-21(administered every 21 days) or R-CHOP-14 (administered every 14 days with granulocyte colony-stimulating factor).143 patients were randomly enrolled in our study (66 patients in R-CHOP-14 group and 77 patients in R-CHOP-21), between 2011 and 2014.
Side effect: Neutropenia,thrombocytopenia,anemia and etc
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010125791N1
Registration date:2016-01-17, 1394/10/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Masoud Sadeghi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3842 5822
Email address
msadeghi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2015-10-01, 1394/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of R-CHOP-21 vs. R-CHOP-14 for untreated stage III and IV B-cell Non-Hodgkin's Lymphoma
Public title
A treatment for Non-Hodgkin's Lymphoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age; sex; type of NHL; subtype; Ki-67 index; organomegaly; lymphadenopathy; radiotherapy; anatomic sites of NHL; recurrence
Exclusion criteria: cardiovascular; renal; hepatic disease (hepatitis B or hepatitis C; T-cell lymphoma;patients with initial neutrophil count <1.5×109 per L; initial platelet count <100×109 per L
Age
From 16 years old to 82 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
143
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Kermanshah University of Medical Sciences and Health Services
Street address
Kermanshah University Of Medical Sciences, Beheshti blv, kermanshah, iran Kermanshah Kermanshah Iran, Islamic Republic Of
City
Kermanshah
Postal code
Approval date
2016-01-05, 1394/10/15
Ethics committee reference number
KUMS.REC.1394.227
Health conditions studied
1
Description of health condition studied
Non-Hodgkin lymphoma, unspecified
ICD-10 code
C85.9
ICD-10 code description
Non-Hodgkin lymphoma, unspecified
Primary outcomes
1
Description
Survival
Timepoint
2 and 5 years
Method of measurement
Observtion
Secondary outcomes
1
Description
Neutropenia
Timepoint
every 14 days and every 21 days
Method of measurement
Experimental
Intervention groups
1
Description
R-CHOP-21:intravenous cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 (maximum dose 2 mg), and rituximab (MabThera®) 375 mg/m2 on day 1, and oral prednisolone 100 mg/m2 on days 1–5, administered every 21 days.
Category
Treatment - Drugs
2
Description
R-CHOP-14 group: intravenous cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 2 mg, rituximab(MabThera®) 375 mg/m2 on day 1, and oral prednisolone 100 mg on days 1–5, administered every 14 days with G-CSF.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Research Center
Full name of responsible person
Dr. Mehrdad Payandeh
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University Of Medical Sciences and Health Services
Full name of responsible person
Dr. Behrooz Hamzeh
Street address
Kermanshah University Of Medical Sciences, Beheshti blv, kermanshah, iran Kermanshah Kermanshah Iran, Islamic Republic Of
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University Of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Masoud Sadeghi
Position
MSc
Other areas of specialty/work
Street address
Medical Bology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83 3842 5822
Fax
Email
sadeghi_mbrc@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Payandeh
Position
Assistant professor
Other areas of specialty/work
Street address
Emam Reza Hospital, bone marrow transplant ward,Kermanshah University of Medical Sciences, Kermanshah, Iran.
City
Kermanshah
Postal code
Phone
+98 83 3728 2400
Fax
Email
md.payandeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)