The Assessment of Efficacy for Neoadjuvant Chemotherapy with Modified FOLFOX6 compared to Chemoradiation for the Management of Locally Advanced Rectal Cancer: A Promising Therapeutic Approach
Investigation the effect of neoadjuvant chemotherapy on locally advanced rectal cancers including pathological complete response, 3-years disease free survival, down-staging of invasion, Down-staging if lymph nodes
Design
Two arm parallel group randomised trial for assessing effectiveness of chemotherapy in locally sdvanced rectal cancers.
After initial steps, patients entered intervention or control groups as the odds numbers entered intervention group and even numbers entered control group.
Settings and conduct
patients with locally advanced rectal cancers from Hamadan proviance and its neighbers Kordestan and kermanshah, entered stydy.
the main centers were Mahdieh radiotjerapy and oncology center, besat Hospital,bu0ali Hospital, Razi lab,...
Participants/Inclusion and exclusion criteria
Inclusion: locally advanced rectal cancers, age between18-75/No distant metastasis/proper blood condition/ Proper renal fonction/Proper liver function
Exclusion: recurrent rectal cancers/ previous pelvic radiation/ History of other malignancyAfter initial
Intervention groups
Adding neoadjuvant chemotherapy
Main outcome variables
Pathologic complete response, Down-staging of didease including decreaseing of invasion and lymphnodes involvement, 3-years disease free survival
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210308050628N1
Registration date:2023-12-08, 1402/09/17
Registration timing:retrospective
Last update:2023-12-08, 1402/09/17
Update count:0
Registration date
2023-12-08, 1402/09/17
Registrant information
Name
Kamal Mohammadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3264 0020
Email address
km_282@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-01-10, 1393/10/20
Expected recruitment end date
2019-11-30, 1398/09/09
Actual recruitment start date
2015-01-10, 1393/10/20
Actual recruitment end date
2019-12-30, 1398/10/09
Trial completion date
2023-06-28, 1402/04/07
Scientific title
The Assessment of Efficacy for Neoadjuvant Chemotherapy with Modified FOLFOX6 compared to Chemoradiation for the Management of Locally Advanced Rectal Cancer: A Promising Therapeutic Approach
Public title
Investigating the effect of neoadjuvant chemotherapy on locally advanced rectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-75
Rectal cancer(Adenocarcinoma) confirmed by pathology
locally advanced tumors
No distant metastasis
Proper Performance status(PS: 0-1)
proper blood condition
proper renal function
proper liver function
Exclusion criteria:
Recurrent rectal cancer
previous pelvic radiotherapy
history of other malignancy
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
300
Actual sample size reached:
286
Randomization (investigator's opinion)
Randomized
Randomization description
The patients referred to the Cancer center after essential and necessary task, entered the intervention and control group respectively. In other word, odds number entered intervention group and even numbers entered control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients had no role in selecting treatment type.
Pathologists and Surgeons did not know the treatment type.
The analysis team did not know the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee in Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Blv
City
Hamadan
Province
Hamadan
Postal code
65178
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.UMSHA.REC.1401.768
Health conditions studied
1
Description of health condition studied
Locally advanced Rectal cancers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pathological complete response, down-staging of tumor invasion and lymph nodes involvement, 3-years disease free survival
Timepoint
Before treatment, During treatment, after treatment and 3 years follow up