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Clinical trial to evaluate the resectability rate and tumor response to neoadjuvant chemo radiotherapy in patients with locally advanced proximal gastric cancer and esophagogastric cancer.

Protocol summary

Summary
The aim of the study: Evaluation of resectability rate and tumor response to neoadjuvant chemo radiotherapy in patients with locally advanced proximal gastric cancer and esophagogastric cancer Study design: Clinical trial Study population: Patients with locally advanced proximal gastric cancer and esophagogastric cancer referred to Omid hospital of Mashhad. Inclusion criteria: All patients with locally advanced proximal gastric cancer and esophagogastric cancer who have positive biopsy results and has been filled the consent form informally. Exclusion criteria: Patients (illness) at stage I,IV - patient dissatisfaction- comorbid diseases that prevent oncologic treatment- previous cancer- previous chemotherapy or radiotherapy- hepatic and renal dysfunction that prevents oncologic treatments- Performance status 3,4 ECOG Intervention : All patients with locally advanced proximal gastric cancer and esophagogastric cancer that have positive biopsy result are considerated for receiving chemo radiation therapy before surgery. Before treatment, patients undergo a complete evaluation of metastatic spread. Measurements before treatment include: a full clinical examination, endoscopy and biopsy, endosonography, abdominal CT scan, chest radiography, complete blood tests including CBC, liver and renal function test. After criteria approval, eligible patients entered Preoperative Chemo radiation trial. Therapeutic regimen including: chemotherapy and radiation with capecitabin 625 mg/m2/bid as otherwise afford , 5 - fluorouracil 325 mg/m2 and leucovorin 20/mg2 at the first four days and the last three days of radiotherapy . Radiotherapy with a total dose of 4500 cgy with two fields AP-PA and with a fractions of 180 - 200 cgy done. During third to fourth week of treatment, blood test (CBC) is controlled (to control hematologic side effects) and also controlled before surgery. 4 - 6 weeks after completing Chemo radiation, patients are referred for surgery. After surgery, specimens are evaluated for pathologic response and resectability. The postoperative morbidity and mortality includes leakage is investigated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014072015044N1
Registration date: 2014-07-20, 1393/04/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-07-20, 1393/04/29
Registrant information
Name
Soodabeh Shahidsales
Name of organization / entity
Cancer research center
Country
Iran (Islamic Republic of)
Phone
+98 51 1846 1518
Email address
shahidsaless@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Mashhad University of Medical Sciences.
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to evaluate the resectability rate and tumor response to neoadjuvant chemo radiotherapy in patients with locally advanced proximal gastric cancer and esophagogastric cancer.
Public title
Neoadjuvant chemoradiotheraphy in patients with locally advanced gastric cancer
Purpose
Treatment
Inclusion/Exclusion criteria
The main inclusion criteria: All patients with locally advanced proximal gastric cancer and esophagogastric cancer who have positive biopsy results and has been filled the consent form informally. The main exclusion criteria: patients (illness) at stage I and IV; patient dissatisfaction; comorbid diseases that prevent oncologic treatment; previous cancer; previous chemotherapy or radiotherapy; hepatic and renal dysfunction that prevents oncologic treatments; Performance status 3,4 ECOG
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Daneshgah st., Ghoreshi Building
City
Mashhad
Postal code
Approval date
2012-02-18, 1390/11/29
Ethics committee reference number
1

Health conditions studied

1

Description of health condition studied
Proximal gastric cancer
ICD-10 code
C16.1
ICD-10 code description
Fundus of stomach

2

Description of health condition studied
Gastro-oesophageal cancer
ICD-10 code
C16.0
ICD-10 code description
Gastro-oesophagea cancerl

Primary outcomes

1

Description
Evaluation of resectability rate and tumor response in patients with locally advanced proximal gastric cancer and esophagogastric cancer treated with neoadjuvant chemoradiotheraphy
Timepoint
Pathologic Evaluation of surgical specimen
Method of measurement
Pathologic response

Secondary outcomes

1

Description
Rate of surgical copmplication
Timepoint
Post operation
Method of measurement
Incisional leek,post op mortality

Intervention groups

1

Description
All patients with locally advanced proximal gastric cancer and junction esophagogastric cancer receive Preoperative Chemoradiation therapy before surgery are candidates with a positive biopsy . Before treatment , patients underwent a complete evaluation of metastatic spread , and are to be excluded . Measures before treatment included a full clinical examination , endoscopy and biopsy , Endosonography , abdominal CT , chest radiography , complete blood tests including CBC , liver and renal function test . After approval criteria , and the patients entered Trial Preoperative Chemoradiation placed. Drug regimens , including chemotherapy and radiation Capecitabin 625 mg/m2/Bid as otherwise afford , 5 - flourouracil 325 mg/m2 and locoverin20 mg /m2 of 4 first days and 3 last days of radiotherapy . Radiotherapy with a total dose of 4500 cgy with two field AP-PA with fractions 180 - 200 cgy done . Third to fourth week of treatment, blood tests ( CBC ) is controlled ( to control hematologic effects ) controlled blood testing before surgery . 4 -6 weeks after Chemoradiation patient is referred for surgery . After surgical pathology specimens of pathologic response and resection of the features represented. The morbidity and mortality of postoperative incisional surgery includes Leak is investigated.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad Omid Hospital
Full name of responsible person
Soodabeh Shahidsales
Street address
Omid Hospital, Koohsangi st. , Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Zohreh Boostanian
Street address
Vice chancellor for research, Office building Qureshi, University st., Mashhad
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 Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Omid Hospital
Full name of responsible person
Ali Emadi Torghabeh
Position
Assistant of radiation oncology
Other areas of specialty/work
Street address
Omid Hospital, Koohsangi st., Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 1846 1518
Fax
Email
emadita1@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Cancer research center , Faculty of medicin, Mashhad University of Medical Sciences
Full name of responsible person
Soodabeh Shahidsales
Position
Assistant Professor of Radiation Oncology
Other areas of specialty/work
Street address
Cancer Research Center, Omid Hospital, Koohsangi st.,Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 1846 1518
Fax
Email
shahidsaless@mums.ac.ir
Web page address
http://www.mums.ac.ir/cancer

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University OF Medical Sciences
Full name of responsible person
Ali Emadi Torghabeh
Position
Assistant
Other areas of specialty/work
Street address
Omid Hospital, Koohsangi st., Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 1854 6084
Fax
Email
emadita1@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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