Comparison of the efficacy and the toxicity of two chemoradiation protocols of cisplatin-irinotecan and carboplatin-paclitaxol, in operable esophageal cancer.
The purpose of this study is to evaluate the preoperative chemo-radiation of esophageal cancer with Cisplatin-Irinotecan compared with Paclitaxol/Carboplatin.
Design
Two arm parallel groups randomized trial of preoperative chemoradiation among 100 patients with esophageal cancer
Settings and conduct
In one arm radiotherapy begins 3 weeks after induction chemotherapy with combination of cisplatin 30 mg per square metre and irinotecan 65 mg per square metre, days 1 and 8. The same chemotherapy protocol continue, day 1 and 8, and 29 and 35, during the 5 weeks of 5040 cGy radiotherapy program. In the arm two patients are treated with weekly paclitaxol 50 mg per square metre and carboplatin with AUC 2 during the same 5 weeks 5040 cGy radiotherapy program.Then, patients undergo surgery in both groups. After surgery, patients in the arm1, complete their treatment program with two courses of the same chemotherapy regimens while patients in the arm 2 are followe without any chemotherapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria:primary esophageal cancer(adenocarcinoma or squamous cell carcinma); no distant metastasis; maximum age 75 years; performance Status>70% ; stable hematological status; normal liver and kidney function; patient consent; suitable patient for surgery.
Exclusion Criteria:metastatic disease; cervical esophageal cancer; thracheo-esophageal fistula; another previous or current malignant disease; any major surgery within the past 4 weeks.
Intervention groups
Chemotherapy with the combination of cisplatin 30 mg per square metre and irinotecan 65 mg per square metre on days 1 and 8 every 3 weeks at least 2 cycles during radiotherapy and at most 3 cycles before surgery.
Main outcome variables
Survival Rate
General information
Reason for update
Acronym
Mashhad Esophageal Cancer Treatment Study01
IRCT registration information
IRCT registration number:IRCT20141102019783N5
Registration date:2022-02-06, 1400/11/17
Registration timing:retrospective
Last update:2022-02-06, 1400/11/17
Update count:0
Registration date
2022-02-06, 1400/11/17
Registrant information
Name
Mitra Fazl Ersi
Name of organization / entity
Mashhad University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3846 1516
Email address
fazlm1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
support by deputy of research
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2015-06-22, 1394/04/01
Actual recruitment end date
2021-03-19, 1399/12/29
Trial completion date
2021-03-19, 1399/12/29
Scientific title
Comparison of the efficacy and the toxicity of two chemoradiation protocols of cisplatin-irinotecan and carboplatin-paclitaxol, in operable esophageal cancer.
Public title
Preoperative chemoradiation with cisplatin-irrinotecan compared with carboplatin-paclitaxel in esophageal cancer.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primary esophageal cancer(adenocarcinoma or squamous cell carcinoma) No distant metastasis Maximum age 75 years Performance Status>70% Stable hematologic status Normal liver and kidney function Patient consent suitable for surgery Exclusion Criteria: Metastatic disease Cervical Esophageal Cancer Thracheoesophageal fistula Previous or current another malignant disease Any major surgery within the past 4 weeks.
Exclusion criteria:
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
69
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Regional Committee Of Mashhad University Of Medical Sciences
Street address
Daneshgah Street, Goreishi Building
City
Mashhad
Province
Razavi Khorasan
Postal code
9137744797
Approval date
2015-05-22, 1394/03/01
Ethics committee reference number
IR.MUMS.fm.REC.1394.64
Health conditions studied
1
Description of health condition studied
Esophageal Cancer
ICD-10 code
C15.1-C15.
ICD-10 code description
-Thoracic part of oesophagus-Abdominal part of oesophagus-Cardia
Primary outcomes
1
Description
Survival Rate
Timepoint
1- Every 3 months after start of intervention. 2- Following every cycle of chemotherapy
Method of measurement
Months that patient is without any sign or recurrent disease and survive after start of intervention.
Every 3 months after start of intervention also following every cycle of chemotherapy.
Method of measurement
Months that patient survive after start of intervention.
Intervention groups
1
Description
Patients treat with the combination of cisplatin 30 mg per square meter and irinotecan 65 mg per square meter in days1 and 8 every 3 weeks at least 2 cycles during a course of 5-6 weeks radiotherapy of 5040 cGy and at most 3 cycles before surgery. Surgery is scheduled for 4-8 weeks after ending chemoradiation protocol.
Category
Treatment - Drugs
2
Description
Chemoradiation with paclitaxel-carboplatin regimen as a weekly schedule of paclitaxel 50 mg per square meter and carboplatin AUC=2 during 5-6 weeks radiotherapy of 5040 cGy. Surgery is scheduled for 4-8 weeks after ending chemoradiation protocol.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Mitra Fazl Ersi
Street address
Emam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
fazlm1@mums.ac.ir
2
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Mitra Fazl Ersi
Street address
Khohsangi streat, Alandasht square, Omid hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3846 1518
Email
fazlm1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciencesice
Full name of responsible person
Marjan Ardakanian
Street address
Ghoreishi Building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
1025469852
Phone
+98 51 3841 2081
Email
ArdakanianM1@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciencesice