FLOT induction chemotherapy before neoadjuvant chemoradiotherapy and resectability and pathologic response in patients with esophagogastric junction and Proximal gastric adenocarcinomas
Determinig tumor removal rate and complete pathologic response after surgery for advanced adenocarcinoma of the esophagogastric junction and proximal stomach using induction chemotherpy FLOT before neoadjuvant chemoradiotherapy
Design
Patients receive two courses of FLOT chemotherapy before neoadjuvant concurrent chemoradiation.Simulation based on CT scan will be used to perform radiotherapy.Patients will be subjected to a CT scan of the thoracoabdominopelvic in the supine position.The protocol of concurrent chemotherapy with radiotherapy will be weekly Paclitaxel and Carboplatin during the radiotherapy period
Settings and conduct
Mashhad:Imam Reza Hospital,Department of Radio Oncology and Omid Hospital
Participants/Inclusion and exclusion criteria
log in:
Appropriate performance status(ECOG score0-1)
Presence of pathologic diagnosis based on adenocarcinoma of the distal of esophagus and the proximal of stomach and the esophago-gastric junction
Resectable malignant lesion
log out:
Presence of siginificant comorbidity
History of collagen vascular disease
Presence of metastatic disease in initial review
History of previous chemotherapy or radiotherapy
History of malignancy of solid organs during the last 5 years( except skin BCC/SCC and cervical CIN which were treated with surgery
Advanced inoperable cancer
Pregnancy and breastfeeding
Intervention groups
Receiving 2 course of chemotherapy before concurrent neoadjuvant chemoradiotherapy
Main outcome variables
Resection of malignant lesion during surgery
Tumor response to neoadjuvant therapy in pathology after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210706051800N1
Registration date:2022-09-19, 1401/06/28
Registration timing:prospective
Last update:2022-09-19, 1401/06/28
Update count:0
Registration date
2022-09-19, 1401/06/28
Registrant information
Name
Zohre Pishevar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3869 0835
Email address
pishevarfz971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
FLOT induction chemotherapy before neoadjuvant chemoradiotherapy and resectability and pathologic response in patients with esophagogastric junction and Proximal gastric adenocarcinomas
Public title
effect of chemotherapy befor chemoradiation on response rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Appropriate performance status(ECOG score0-1)
Presence of pathologic diagnosis based on adenocarcinoma of the distal of esophagus and the proximal of stomach and the esophago-gastric junction
Resectable malignant lesion(stageIB-IIIB)
Exclusion criteria:
Presence of siginificant comorbidity included uncontrolled diabetus mellitus,uncontrolled hypertension,history of ischemic heart disease and CABG,history of cerebrovascular accident(CVA),grade 2 or more neuropathy, failure of bone marrow(lymphopenia and leukopenia and thrombocytopenia in initial review),heart failure(EF≤45%),renal dysfunction(GFR<50 mg/m),hepatic dysfunction (AST/ALT≥3×ULN و Billt≥1.5×ULN) which prevents the prescription of neoadjuvant or surgery for the patient
History of collagen vascular disease
Presence of metastatic disease in initial review
History of previous chemotherapy or radiotherapy
History of malignancy of solid organs during the last 5 years( except skin BCC/SCC and cervical CIN which were treated with surgery
Advanced inoperable cancer
Pregnancy and breastfeeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Medical Science university,Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2021-06-01, 1400/03/11
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.153
Health conditions studied
1
Description of health condition studied
Locally advanced adenocarcinoma of the esophago gastric junction and proxmimal of the stomach
ICD-10 code
C16.0
ICD-10 code description
Malignant neoplasm of cardia
Primary outcomes
1
Description
Resection of malignant lesion during surgery
Timepoint
Post surgery based on pathologic report
Method of measurement
إased on residual tumor classification on including R0:lack of micro and macroscopic residue R1:microscopic residue and positive surgical margin and lack of gross residue R2:gross residue
2
Description
Tumor response to neoadjuvant therapy in pathology after surgery
Timepoint
Post surgery based on pathologic report
Method of measurement
Based on American Institue of pathology:1)Complete response in the sense of the absence of tumoral cells in the primary location of the tumor and lymph nodes 2)partial response: presence of limited tumor remnants with fibrosis in the primary site and examined nodes and 3)No response:presence of tumoral cells in the primary location of the tumor and lymph nodes
Secondary outcomes
1
Description
Complications of chemotherapy
Timepoint
During induction chemotherapy every 2 weeks and during chemoradiation weekly
Method of measurement
History,Physical exam, lab test include complete blood count and kidney function test and liver function test and complication of treatment based on Common Terminology Criteria for Adverse Events(CTCAE-EORTC)
2
Description
Complications of Radiotherapy
Timepoint
Weekly During Radiotherapy and then monthly
Method of measurement
Complication of treatment based on Common Terminology Criteria for Adverse Events(CTCAE-EORTC)
Intervention groups
1
Description
Intervention group: In the intervention group, before neoadjuvant chemoradiotherapy, patients will undergo two cycles of chemotherapy with FLOT regimen (containing fluorouracil, leucovorin, oxaliplatin and docetaxel). Inpatient FLOT chemotherapy protocol with drugs oxaliplatin 85 mg/m2 over two hours in dextrose water serum on the first day, Leucovorin 200 mg/m2 over two hours in normal saline serum on the first day, docetaxel 50 mg/m2 within one hour in normal saline serum on the first day and 5 fluorouracil 2600 mg/m2 within 24 hours in normal saline serum on the first day [or if the treating physician sees fit, infusion of 1200 mg/m2 daily within 48 hours]. To perform radiotherapy, simulation based on CT scan will be used. Patients will be subjected to a CT scan of the thorax and abdomen in the supine position. The chemotherapy protocol will be simultaneous with radiotherapy in the form of paclitaxel (50 mg/m2 ) and carboplatin (AUC=2) weekly during the radiotherapy period.
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The need to share non-identifiable personal data of patients is not felt individually, and it is sufficient to determine the benefits of the intervention performed in all patients or a subgroup of them with special characteristics.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
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
Title and more details about the data/document
The general demographic information of the patients will be published by dividing them into specific subgroups, as well as the main and secondary outcomes of the study in each specific subgroup.
When the data will become available and for how long
After the publication of the article resulting from the study
To whom data/document is available
For researchers after obtaining permission from the subordinate authorities in the university
Under which criteria data/document could be used
To use the documents in similar academic studies and after obtaining the necessary permits
From where data/document is obtainable
Vice President of Research and Technology of Mashhad University of Medical Sciences
What processes are involved for a request to access data/document
Sending the request to the research and technology vice-chancellor of the university and referring them to the director or research vice-chancellor of the radio-oncology department