Determination of the pathological response of localized or locally advanced esophageal carcinoma to induction chemotherapy and concurrent chemotherapy with hypofractionated radiotherapy before surgery.
Determination of the pathological response of localized or locally advanced esophageal carcinoma to induction chemotherapy and concurrent chemotherapy with hypofractionated radiotherapy before surgery.
Design
An interventional trial, phase 2, without a control group, on 43 patients
Settings and conduct
Patients with esophageal cancer who have endoscopic biopsy confirming the diagnosis of SCC or adenocarcinoma and are referred to Omid, Imam Reza, and Hasheminejad hospitals in Mashhad are considered. Patients undergoing staging workup with barium swallowing x-ray and CT scan of the thorax and abdomen for local and distant lymphatic metastasis. Patients suspected of having a primary T1 or T4 tumor Will also be reviewed with endoscopic ultrasonography. Routine laboratory tests, including complete blood counts, liver and kidney function tests, and blood albumin levels are also requested.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The presence of carcinoma in the thoracic or abdominal esophagus; Functional status greater or equal to 70% of the Karnofsky standard or equal or less than one of the ECOG standard; Presence of grade 3 and higher dysphagia or disease stage in T(2-4) N(0) M(0) or (any)T N(+) M(0) based on staging findings; Consent to complete the treatment program, including surgery.
Exclusion criteria: Existence of metastatic disease; Presence of cervical esophageal carcinoma; Existence of invasion to heart, trachea, bronchus or aorta; Dissent to surgery; Existence of a previous history of cancer or other comorbidities that prevent the full implementation of the treatment program.
Intervention groups
Patients with esophageal carcinoma will undergo induction chemotherapy and then concurrent chemotherapy with hypofractionated radiotherapy, and after that tumor removal surgery will be performed for the patients.
Main outcome variables
Rate of pathological response
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210623051676N1
Registration date:2022-02-04, 1400/11/15
Registration timing:registered_while_recruiting
Last update:2022-02-04, 1400/11/15
Update count:0
Registration date
2022-02-04, 1400/11/15
Registrant information
Name
Ali Emadi Torghabeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 6082
Email address
emadita@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-28, 1400/08/06
Expected recruitment end date
2024-01-26, 1402/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the pathological response of localized or locally advanced esophageal carcinoma to induction chemotherapy and concurrent chemotherapy with hypofractionated radiotherapy before surgery.
Public title
hypofractionated radiotherapy in esophageal carcinoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
carcinoma in thoracic or abdominal esophagus
performance status above or equal to 70% in karnofsky criteria or less or equal to 1 in ECOG criteria
presence of 3rd grade or more dysphasia or disease in T2-T4 N0 M0 or any T N+ M0 stage
consent to the whole treatment program including surgery
Exclusion criteria:
presence of metastatic disease
presence of cervical esophagus
invasion to heart, trachea, bronchus or aorta
dissent to surgery
history of cancer or other diseases that interfere to complete the treatment program
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
43
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 Mashhad University of Medical Sciences
Street address
omid hospital, koohsangi Avn.
City
Mashhad
Province
Razavi Khorasan
Postal code
1377591766
Approval date
2021-10-27, 1400/08/05
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.482
Health conditions studied
1
Description of health condition studied
esophageal cancer
ICD-10 code
C15.9
ICD-10 code description
Malignant neoplasm of esophagus, unspecified
Primary outcomes
1
Description
Percentage of pathological response based on tumor necrosis in microscopic examination
Timepoint
4 weeks after completion of neoadjuvant chemoradiotherapy
Method of measurement
Pathological evaluation
Secondary outcomes
1
Description
scale of dysphagia
Timepoint
before the intervention and after completing treatment
Method of measurement
dysphagia severity scale
Intervention groups
1
Description
Intervention group: Received 3 to 5 courses of weekly induction chemotherapy with paclitaxel (50 mg / m2) and carboplatin (AUC 2) followed by hypofractionated radiotherapy with a total dose of 40 Gy and 2.5 Gy per fraction
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid hospital
Full name of responsible person
Shervin Mashreghi Moghaddam
Street address
Omid hospital, Koohsangi Avn.
City
Mashhad
Province
Razavi Khorasan
Postal code
9858795576
Phone
+98 51 3843 9335
Email
emp_shervin@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Deputy of Research and Technology., Qoreshi building., Beside Hoveize cinama., Daneshgah Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
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
Shervin Mashreghi Moghaddam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Omid hospital., Koohsangi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9875674442
Phone
+98 51 3843 9335
Email
emp_shervin@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shervin Mashreghi Moghaddam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Omid hospital., Koohsangi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9875674442
Phone
+98 51 3843 9335
Email
emp_shervin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shervin Mashreghi Moghaddam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Omid hospital., Koohsangi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9875674442
Phone
+98 51 3843 9335
Email
emp_shervin@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
all of data after making persons undetectable
When the data will become available and for how long
after publishing the outcomes
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For research, treatment and educational purposes
From where data/document is obtainable
Refer to Shervin Mashreghi Moghaddam via email address or whatsapp number:
emp_shervin@yahoo.com
00989358663171
What processes are involved for a request to access data/document