Due to the novelty of using neoadjuvant chemoradiotherapy in advanced localized cardia tumor to reduce the stage of the disease and the few studies that have been done in this field, this study designed to investigate the effect of neoadjuvant chemoradiotherapy in reducing the disease stage of cardia tumor. Evaluation of the outcomes performed before and after the intervention.
Design
This study is a single arm clinical trial that will be performed on 60 patients. The outcome will be assessed before and after the intervention and evaluated by the blinded assessment team.
Settings and conduct
This clinical trial will be performed in Imam Reza AS Hospital in Tabriz on the patients with a diagnosis of cardia cancer and tumor staging will be done. After the intervention, the effect of chemoradiotherapy on reducing the stage of tumor will be evaluated. Blinding will be performed for researchers assessing the stage of the disease before and after the intervention.
Participants/Inclusion and exclusion criteria
All patients with a diagnosis of cardia with Inclusion criteria:
Patients aged 80-18 years
Confirmation of advanced localized cardiac adenocarcinoma
Not receiving previous chemotherapy and radiotherapy
Suitable kidney, liver and bone marrow function
Performance status less than equal 2
Non-inclusion criteria:
Distant metastasis
Patient dissatisfaction with neoadjuvant mototherapy
Peritoneal carcinoma
Intervention groups
Chemotherapy regimen used in FC patients (5-fluorouracil 800 mg/m2 intravenously, continuous intravenous infusion for 24 hours daily on days 1 to 5 and cisplatin 15 mg/m2 intravenously, daily injection on days 1 to 5 for two courses It will be every 21 days. The patients will be treated for 25 sessions of 45Gy radiotherapy for 2 minutes, high energy - 18 mV.
Main outcome variables
The tumor staging before and after chemoradiotherapy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140203016473N12
Registration date:2021-02-07, 1399/11/19
Registration timing:registered_while_recruiting
Last update:2021-02-07, 1399/11/19
Update count:0
Registration date
2021-02-07, 1399/11/19
Registrant information
Name
Farzad Kakaei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
fkakaei@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Neoadjuvant Chemoradiotherapy on Downstaging of Locally Advanced Cancer of Cardia and patient's survival
Public title
Effect of chemoradiotherapy on locally advanced cancer of Cardia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 18 to 80 years old
Confirmed advanced localized cardiac adenocarcinoma (stage T3, T4, T2 with lymph node involvement)
No history of previous chemotherapy and radiotherapy
Proper function of the kidney (serum creatinine ≤ 1.5 mg / dl)
Proper function of the liver (serum bilirubin ≤ 1.5 mg / dl)
Proper function of the bone marrow (neutrophil count> 1500 per microliter, platelet count> 100 thousand and Hb> 10)
Performance Status ≤ 2
Exclusion criteria:
Distant metastasis
Patient dissatisfaction with neoadjuvant therapy
Stages T1 and T2 without lymph node involvement (according to the AJCC staging system)
Peritoneal carcinoma
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor who is responsible for assessing the stage of the disease before and after the intervention (using the results of radiological reports) will be blinded to whether the intervention was performed on patients (before or after the intervention).
Placebo
Not used
Assignment
Single
Other design features
In this study, all patients with cardiac cancer diagnosis will be examined for the stage of tumor before and after receiving chemoradiotherapy .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza (AS) Hospital, Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5158646978
Approval date
2020-09-14, 1399/06/24
Ethics committee reference number
IR.TBZMED.REC.1399.620
Health conditions studied
1
Description of health condition studied
Cardia cancer
ICD-10 code
C16.0
ICD-10 code description
Malignant neoplasm of cardia
Primary outcomes
1
Description
The stage of cardiac cancer after chemoradiotherapy intervention
Timepoint
4 to 6 weeks after the intervention
Method of measurement
Staging of heads based on Tumor, Node, Metastases (TNM) system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients on FC diet containing 5-fluorouracil 800 mg / m2 intravenously (Alhavi Pharmaceutical Co.), continuous intravenous infusion for 24 hours daily on days 1 to 5 and cisplatin 15 mg / m2 intravenously (Sobhan Oncology Pharmaceutical Co.), daily injection on days 1 to 5 for two periods Every 21 days with 25 sessions of 45Gy radiotherapy for 2 minutes, high energy - 18 mV
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Tabriz University of Medical Sciences
Full name of responsible person
Farzad Kakai
Street address
Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5158646978
Phone
+98 41 3337 8093
Email
fkakaei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleiman Pour
Street address
Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5158646978
Phone
+98 41 3335 7310
Email
Research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Kakai
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5158646978
Phone
+98 41 3337 8093
Email
fkakaei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Kakai
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5158646978
Phone
+98 41 3337 8093
Email
fkakaei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Araz Moin
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5158646978
Phone
+98 41 3337 8093
Email
araz.moin1985@gmail.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
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