Evaluation of the response and adverse effects of total neoadjuvant therapy (TNT) of advanced localized rectal cancer: a before-after clinical trial without control group
To assess the response and adverse effects of total neoadjuvant therapy (TNT) of advanced localized rectal cancer
Design
This is a before-after clinical trial without control group, in which eligible patients will be enrolled.
Settings and conduct
This study will be performed in the Imam Khomeini Clinic in Hamadan city on 25 eligible patients with advanced localized rectal cancer. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 75 years
Advanced localized rectal cancer
Normal liver, kidney and bone marrow condition
Exclusion criteria:
Previous chemotherapy
Former pelvic radiotherapy
Existence of distant metastasis
Intervention groups
Intervention group:
Combination therapy of concomitant chemoradiotherapy includes: radiotherapy with 18 MV photon and total dose of radiotherapy 45 to 50.4 Gy in 25 to 28 sessions plus chemotherapy with 5FU injected at a dose of 1000 mg/m2 daily on the first to fifth days in the first week and the first to fifth days of the fifth week or 5FU orally at a dose of 825 mg/m2 every 12 hours on all days of radiotherapy. Four weeks after concomitant chemoradiotherapy, patients receiving chemotherapy with the FOLFOX regimen include the following drugs: Oxaliplatin at a dose of 85 mg/m2 on the first day of each course and 5FU at a dose of 600 mg/m2 on the first and second days of each course and Calcium Folinate at a dose of 200 mg /m2 on the first and second days of each course. Each course is 2 weeks apart and lasts up to 6 months.
Main outcome variables
Primary outcome:
Complete pathological response, local recurrence, distant metastasis overall survival
Secondary consequence:
Hematologic and non-hematologic complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N431
Registration date:2022-06-19, 1401/03/29
Registration timing:prospective
Last update:2022-06-19, 1401/03/29
Update count:0
Registration date
2022-06-19, 1401/03/29
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the response and adverse effects of total neoadjuvant therapy (TNT) of advanced localized rectal cancer: a before-after clinical trial without control group
Public title
Evaluation of the response and adverse effects of total neoadjuvant therapy (TNT) of advanced localized rectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 75 years
Advanced localized rectal cancer
Normal liver, kidney and bone marrow condition
Exclusion criteria:
Previous chemotherapy
Former pelvic radiotherapy
Existence of distant metastasis
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-12-12, 1400/09/21
Ethics committee reference number
IR.UMSHA.REC.1400.719
Health conditions studied
1
Description of health condition studied
Rectal cancer
ICD-10 code
C18.7
ICD-10 code description
Malignant neoplasm of sigmoid colon
Primary outcomes
1
Description
The rate of complete pathological response in surgery
Timepoint
6 to 8 weeks after the end of the intervention
Method of measurement
By pathological evaluation
2
Description
Local recurrence rate
Timepoint
Every 3 to 6 months up to 2 years after the end of the intervention
Method of measurement
By measuring tumor marker CEA and colonoscopy and pelvic CT scan
3
Description
Presence of distant metastasis
Timepoint
Every 3 to 6 months up to 2 years after the end of the intervention
Method of measurement
By CT scan of the chest and abdomen
4
Description
Overall survival rate
Timepoint
Up to 2 years after the end of the intervention
Method of measurement
By taking a history
Secondary outcomes
1
Description
Possible acute and chronic hematologic and non-hematologic complications
Timepoint
up to 2 years after the end of the intervention during patient follow-up
Method of measurement
By taking history, clinical examination and blood test
Intervention groups
1
Description
Intervention group: Combination therapy of concomitant chemoradiotherapy includes: radiotherapy with 18 MV photon and total dose of radiotherapy 45 to 50.4 Gy in 25 to 28 sessions plus chemotherapy with 5FU injected at a dose of 1000 mg/m2 daily on the first to fifth days in the first week and the first to fifth days of the fifth week or 5FU orally at a dose of 825 mg/m2 every 12 hours on all days of radiotherapy. Four weeks after concomitant chemoradiotherapy, patients receiving chemotherapy with the FOLFOX regimen include the following drugs: Oxaliplatin at a dose of 85 mg/m2 on the first day of each course and 5FU at a dose of 600 mg/m2 on the first and second days of each course and Calcium Folinate at a dose of 200 mg /m2 on the first and second days of each course. Each course is 2 weeks apart and lasts up to 6 months. Another chemotherapy regimen is XELOX, which include the following drugs: oral capsaicin 1000 mg/m2 every 12 hours for 2 weeks and then discontinued and repeated, plus an injection of oxaliplatin 130 mg/m2 on the first day of each course. Each course is 3 weeks apart and lasts up to 6 months. Patients will undergo surgery 6 to 8 weeks after the end of chemotherapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Clinic in Hamadan city
Full name of responsible person
Mandana Biniaz
Street address
Imam Khomeini Clinic, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3832 1371
Email
mandana.biniaz.med@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mandana Biniaz
Position
Resident of Radio-Oncology
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mandana.biniaz.med@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Abdolazim Sedighi Pashaki
Position
Radio-Oncologist
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
a.sedighipashaki@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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