A survey on different chemoradiation of esophageal cancer with cisplatin and irrinotecan compered with paclitaxol /carboplatin and evaluation of their effect and toxicity
In this prospective randomized study, patient with squamous cell carcinoma or adenocarcinoma of esophagus or cardia and no distant metastasis, candidate for infinitive chemoradiation are taking part.
Methods: In arm 1 (one arm) radiotherapy begins 3weeks after induction chemotherapy with combination regimes Cispelatin 30mg/m2 and Irrinotecan 65mg/m2 days 1 and 8.In same chemotherapy protocol continue, day 1 and 8, and 29 and 35, during the 5 weeks 5040CGry radiotherapy program. Afterward, patients in the arm complete their treatment program with two courses of three weekly apart of the same chemotherapy regimens.In the arm two (another arm) patients are treated with weekly paclitaxol 50mg/m and carboplatin (AUC:2 ) during a 5 weeks ,5040CGray radiotherapy program.Patients followed up and the toxicity of treatment in both arms and DFS and OS are evaluated.
Iinclusion criteria:Primery Esophageal or Cardioesoohageal ٍCancer(Adenocarcinoma or Scc);Without eny distant metastas;Maximum age 75 years ;Performance Status>70% ;Hemotologically Stable; Normal liver and kidney function; Patient Satisfaction; Unfit patient for surgery.
Exclusion Criteria;Metastatic disease; Cervical Esophageal Cancer; Thracheoesophageal fistula; Another previous or current malignant disease ; Any surgery performed within the past 4 weeks; According to the judgment of physition.
Primary outcome:Survival Rate
Secondary outcome:Disease Free Survival -toxcicity
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110219783N1
Registration date:2017-07-24, 1396/05/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-24, 1396/05/02
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
Investigator
Expected recruitment start date
2016-05-12, 1395/02/23
Expected recruitment end date
2018-05-13, 1397/02/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey on different chemoradiation of esophageal cancer with cisplatin and irrinotecan compered with paclitaxol /carboplatin and evaluation of their effect and toxicity
Public title
Effect of difinitive chemoradiation with cisplatin-irrinotecan or carboplatin-paclitaxol in esophageal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Iinclusion criteria:Primery Esophageal or Cardioesoohageal ٍCancer(Adenocarcinoma or Scc);Without eny distant metastas;Maximum age 75 years ;Performance Status>70% ;Hemotologically Stable; Normal liver and kidney function; Patient Satisfaction; Unfit patient for surgery.
Exclusion Criteria;Metastatic disease; Cervical Esophageal Cancer; Thracheoesophageal fistula; Another previous or current malignant disease ; Any surgery performed within the past 4 weeks; According to the judgment of physition.
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
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional committee of Mashhad University of Medical Ethics
Street address
Goreishi Building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2016-05-21, 1395/03/01
Ethics committee reference number
IR.MUMS.fm.REC.1394.85
Health conditions studied
1
Description of health condition studied
Chemoradiation Protocols
ICD-10 code
C15.1-C15.
ICD-10 code description
مری توراسیک_مری شکمی_کاردیا
Primary outcomes
1
Description
Survival Rate
Timepoint
1-Every 3 monthes after start of intervention2-Following every cycle of chemothrapy
Method of measurement
1-Monthes that patients survive after intervention2-Questionnaire
Secondary outcomes
1
Description
1-Disease Free Survival 2-toxcicity
Timepoint
1-Every 3 months after start of intervention 2-Following every cycle of chemothrapy
Method of measurement
Monthes that patients survive after start of intervention-qestionnaire
Intervention groups
1
Description
Patients in the arm 1 treat with the combination of cisplatin 30mg/m2 and irrinotecan 65mg/m2 days 1,8 every 3 weeks at least 2 cycles during radiotherapy and 1 cycle before and 2 cycles after chemoradiotherapy .Chemotherapy cycles are prescirbe :platelete> 85000,Hb 8mg/dl, GFR>40 and liver function tests no more than 1.5 times the normal. Radiotherapy course compose 50,40CGy during 5-6 weeks.
Category
Treatment - Drugs
2
Description
Patient in the control arme treat with the combination of paclitaxel 50mg\m2 and carboplatin AUC:2 ,weekly during radiotherapy .
Category
Diagnosis
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
2
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Mitra Fazl Ersi
Street address
Kohsangy Street,Alandasht Square
City
Mashhad
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
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