Evaluating the effect of neoadjuvant chemotherapy on histological response and tumour downstaging
Design
Randomised, parallel group, triple-blind, controlled multi center trial
Settings and conduct
This clinical trial will be conducted at Imam Reza Hospital and Ghaem hospital in Mashhad. Surgeon, pathologist and radiologist and assessor of quality of life, as well as data analyst, will be blinded to the assigned groups.
Participants/Inclusion and exclusion criteria
Non-metastatic colon cancer (Adenocarcinoma) in stage T3 with the involvement of local lymph nodes or T4 with or without the involvement of local lymph node, uncomplicated primary tumour requiring surgery (obstruction, perforation, bleeding), age between 18 and 75 years and ECOG functional status between 0-1
Intervention groups
Performing 6-week chemotherapy with mFOLFOX 6 or CapeOx and then carry out surgery and continue chemotherapy for 18 weeks.
Main outcome variables
Disease Free Survival and histological response after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130819014404N2
Registration date:2018-12-12, 1397/09/21
Registration timing:registered_while_recruiting
Last update:2018-12-12, 1397/09/21
Update count:0
Registration date
2018-12-12, 1397/09/21
Registrant information
Name
Majid Khadem-Rezaiyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9262
Email address
khademrm831@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-30, 1397/09/09
Expected recruitment end date
2019-05-30, 1398/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Neoadjuvant chemotherapy in locally advanced colon cancer: a randomized controlled trial
Public title
Chemotherapy in locally advanced colon cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adnocarcinoma
Stage T3 with lymph node involvement and T4
Non metastatic
Primary tumor without complications which needs surgery (i.e. obstruction, perforation, bleeding)
Age between 18-75
Functional status ECOG between 0-1
Exclusion criteria:
Contraindication for receiving contrast for imaging
Major surgery in less than 28 days prior to recruiting to the study
Co-existence of other cancers
Past medical history of other cancers
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization on individuals was performed using a table of random numbers. Allocation concealment was carried out.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The surgeon, pathologist and radiologist are unaware of allocated groups. Besides, the outcome assessor who evaluates the quality of life is unaware of the allocated groups. The data analyser will be blinded to the intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Medical Faculty of Mashhad University of Medical Sciences
Street address
Medical Faculty, University Campus, Azadi Sq.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2018-07-25, 1397/05/03
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.408
Health conditions studied
1
Description of health condition studied
Cancer of the large intestine
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
Primary outcomes
1
Description
Histological response and down staging of tumor
Timepoint
After surgery
Method of measurement
Pathological and radiological examination
2
Description
Disease Free Survival
Timepoint
One year after intervention
Method of measurement
No relapse of cancer
Secondary outcomes
1
Description
Overall survival
Timepoint
1 year after surgery
Method of measurement
The patient is alive
2
Description
The safety and tolerably of chemotherapy before surgery
Timepoint
60-day mortality after surgery
Method of measurement
The patient is alive
3
Description
Quality of life
Timepoint
At baseline, 6 months and one year after the completion of the study
Method of measurement
ًQuestionnaires EORTC QLQ-CR29 and EORTC QLQ-C30
Intervention groups
1
Description
Intervention group: performing 6 week chemotherapy with mFOLFOX 6 or CapeOx and then carry out surgery and continue chemotherapy for 18 weeks
Category
Treatment - Drugs
2
Description
Control group: Initial surgery followed by chemotherapy with mFOLFOX 6 or CapeOx for 24 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza (p) Hospital
Full name of responsible person
ِDr. Alireza Baari
Street address
Imam Reza (p) Hospital, Imam Reza Sq., Ibn Sina Ave.,
City
Mashhad
Province
Razavi Khorasan
Postal code
91379-13316
Phone
+98 51 3854 3031
Email
dr.alireza.baari@gmail.com
2
Recruitment center
Name of recruitment center
Qaem Hospital
Full name of responsible person
ِDr. Alireza Baari
Street address
Qaem Hospital, Ahmadabad Ave., Shariati Sq.,
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Email
dr.alireza.baari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoreishi Building, Before Golestan Crossroad, Daneshgah Ave., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 2081
Email
Ramresearch@mums.ac.ir
Grant name
Dr. Alireza Baari
Grant code / Reference number
mums-۹۶۱۲۲۸
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohamad Moeini
Position
Fellow of hematology and oncology
Latest degree
Specialist
Other areas of specialty/work
Hematology
Street address
Imam Reza Hospital, Imam Reza Sq., Ibn Sina Ave.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
moeininm901@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Baari
Position
Hematologist and oncologist
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Imam Reza Hospital, Imam Reza Sq., Ibn Sina Ave.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3801 2742
Email
baria@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohamad Moeini
Position
Fellow of hematology and oncology
Latest degree
Specialist
Other areas of specialty/work
Hematology
Street address
Imam Reza Hospital, Imam Reza Sq., Ibn Sina Ave.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
moeininm901@mums.ac.ir
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