Evaluation of treatment outcome of induction chemotherapy and then Neoadjuvant chemoradiotherapy and surgery in locally advanced rectal cancer.
Design
first EUS or MRI abdomiopelvic iand then pan CT is done.if no metastatic then induction chemotherapy with capox regimen every 3 weeks in 2 course then CHRT with capox and 4 weeks later restaging with CT scan and after 6-8 weeks after ChRt then patient goes to surgery .
Settings and conduct
thirty patient of newly diagnosis locally advanced rectal cancer refer to Imam Hossein Hospital is entered in study
Participants/Inclusion and exclusion criteria
1-adenocarcinoma maximum 15 cm from anal verge
2- TNM، T3,4 یاN+
3- 2 ≥ performance status
4- (GFR ≥ 50)
5- liver function tests lower than upper limit normal
6- billirubin lower than 3rd upper limit normal
7- age upper than 18 years and lower than 65
Intervention groups
induction chemotherapy imen 2 courses then chemoradiation wuth capox then surgery was done
Main outcome variables
evaluation add pathologic complete response, R0 resection,sphincter preservation in lower rectum tumors,acute grade 3 hematologic, neurological, diarrhea toxicity or more during chemotherapy and chemoradiation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200420047139N1
Registration date:2020-06-02, 1399/03/13
Registration timing:retrospective
Last update:2020-06-02, 1399/03/13
Update count:0
Registration date
2020-06-02, 1399/03/13
Registrant information
Name
Behnaz Behzadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2221 4868
Email address
behnaz_bzd@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
2018-05-22, 1397/03/01
Actual recruitment end date
2019-05-22, 1398/03/01
Trial completion date
2019-05-22, 1398/03/01
Scientific title
Evaluation of treatment outcome of induction chemotherapy and then Neoadjuvant chemoradiotherapy and surgery in locally advanced rectal cancer
Public title
Evaluation of treatment outcome of induction chemotherapy and then Neoadjuvant chemoradiotherapy and surgery in locally advanced rectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
rectal cancer lower than 15 cm anal verge
T3 or T4 or N+
2 ≥ performance status
GFR ≥ 50
liver function test upper limit normal
bilirubin lower than 3rd upper limit normal
more than 18 years , less thean 65 years
Exclusion criteria:
pathology except adenocarcinoma
T1,2 ,N0
metastatic disease
history of malignancy
history of chemotherapy or radiation therapy
pregnancy and breast feeding
recurrent rectal cancer
medical disease
forrbidden chemotherapy or radiation therapy
Age
From 18 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
29
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
not done before in iranian
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University Of Medical Of Sciences Ehics Committee
Street address
Velenjak,Tehran Province
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-05-22, 1398/03/01
Ethics committee reference number
IR.SBMU.MSP.REC.1397.473
Health conditions studied
1
Description of health condition studied
locally advanced rectal cancer
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum
Primary outcomes
1
Description
pathologic complete response
Timepoint
after surgery
Method of measurement
pathologic evaluation
Secondary outcomes
1
Description
grade 3 or more of acute toxicity
Timepoint
during chemotherapy and chemoradiation
Method of measurement
observation symptoms and lab test
2
Description
R0 Resection
Timepoint
after surgery
Method of measurement
pathology
3
Description
sphincter pereservation
Timepoint
after surgery
Method of measurement
type of surgery
Intervention groups
1
Description
Intervention group: newly diagnosis locally advanced rectal cancer in included.they recived Induction chemotherapy with 2 course of CAPOX regimen every 3 weeksthen ChRt with CAPOX and then surgery after 8 weeks.(capox regimen=capecitabine 1250 mg/m2 po BD d1-14and Oxaliplatin 50mg/m2 iv weekly)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Hospital
Full name of responsible person
Ali Yaghoubi Joybari
Street address
Madani Street
City
Tehran
Province
Tehran
Postal code
12345678910
Phone
+98 21 7343 0211
Email
behnaz_bzd@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin zarghi
Street address
Imam Hussein Hospital,Radiation Oncology Department
City
Tehran
Province
Tehran
Postal code
12345678910
Phone
+98 21 2221 6594
Email
behnaz_bzd@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
Behnaz Behzadi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Imam Hussein hospital,radiation oncology department
City
Tehran
Province
Tehran
Postal code
12345678910
Phone
+98 21 2221 6594
Email
behnaz_bzd@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behnaz Behzadi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Imam Hussein hospital,radiation oncology department
City
Tehran
Province
Tehran
Postal code
12345678910
Phone
+98 21 2221 6594
Email
behnaz_bzd@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behnaz Behzadi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Imam Hussein hospital,radiation oncology department
City
Tehran
Province
Tehran
Postal code
12345678910
Phone
+98 21 2221 6594
Email
behnaz_bzd@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Evaluation of treatment outcome of induction chemotherapy and then Neoadjuvant chemoradiotherapy and surgery in locally advanced rectal cancer.
When the data will become available and for how long
base on programmer decision
To whom data/document is available
all physicians
Under which criteria data/document could be used
base on programmer decision
From where data/document is obtainable
sending email to programmer
What processes are involved for a request to access data/document