Evaluation of resectability rate and tumor complete pathological response in patients with locally advanced proximal gastric cancers receiving neoadjuant chemoradiothrapy
This trial aims to evaluate the complete pathological tumor response and resectability rate in patients with locally advanced proximal gastric cancer and gastroesophageal cancer after concurrent chemoradiotherapy before surgery. Major conditions for entry into the study include performance status 0, 1 and 2; surgery in future treatment planning; and good condition for chemotherapy, radiotherapy and surgery. Exclusion criteria involve metastasis and death. The sample size is 40, and the study is in Phase 2 with no randomization. Patients are selected from Omid and Imam Reza hospitals in Mashhad. Patients undergo complete CT scan of the abdomen and pelvis to confirm the absence of metastasis. Following this, induction chemotherapy is administered with Paclitaxel 50 milligram/square meters/weekly and Carboplatin AUC=2 on a weekly basis for 3 to 6 weeks. Then, the patients will continue chemotherapy with the same protocol along with radiotherapy with a total dose of 45 Gray for 4 weeks. They will be subjected to total gastrectomy after the end of the combined treatment protocol. The primary outcome is resectability rate and complete pathological tumor response. In addition, myelosuppression, nausea, vomiting, and hair loss are examined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070834945N1
Registration date:2017-08-12, 1396/05/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-12, 1396/05/21
Registrant information
Name
Masume Masoudian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3509 8885
Email address
masoudianm941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-01-01, 1394/10/11
Expected recruitment end date
2019-01-01, 1397/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of resectability rate and tumor complete pathological response in patients with locally advanced proximal gastric cancers receiving neoadjuant chemoradiothrapy
Public title
Neoadjuant chemoradiothrapy in treatment of proximal gastric cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: performance status 0, 1 and 2; surgery in future treatment planning; and good condition for chemotherapy, radiotherapy and surgery.
Exclusion criteria: metastasis; death.
Age
No age limit
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
Vice-chancellery for Research, Mashhad University of Medical Sciences, Imam Khomaini St.,
City
Mashhad
Postal code
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
ir.mums.fm.rec.1396.03
Health conditions studied
1
Description of health condition studied
Gastric cancer
ICD-10 code
C16.9
ICD-10 code description
Stomach, unspecified
Primary outcomes
1
Description
Resectability of tumor or R0 resection
Timepoint
After 15 weeks of neoadjuant therapy
Method of measurement
Pathology report after surgery
Secondary outcomes
1
Description
Myelosuppression
Timepoint
every 7 days during treatment
Method of measurement
complete blood count
2
Description
Nausea
Timepoint
On a weekly basis
Method of measurement
Based on the scale provided by Common Terminology Criteria for Adverse Events, Version 4
3
Description
Vomiting
Timepoint
On a weekly basis
Method of measurement
Based on the scale provided by Common Terminology Criteria for Adverse Events, Version 4
4
Description
Hair loss
Timepoint
On a weekly basis
Method of measurement
Based on the scale provided by Common Terminology Criteria for Adverse Events, Version 4
Intervention groups
1
Description
Intervention Group (Concurrent chemoradiotherapy plus surgery): Patients undergo complete CT scan of the abdomen and pelvis to confirm the absence of metastasis. Following this, induction chemotherapy is administered with Paclitaxel 50 milligram/square meters/weekly and Carboplatin AUC=2 on a weekly basis for 3 to 6 weeks. Then, the patients will continue chemotherapy with the same protocol along with radiotherapy with a total dose of 45 Gray for 4 weeks. They will be subjected to total gastrectomy after the end of the combined treatment protocol.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Dr Masume Masoudian
Street address
Kuhsangi Ave., No. 10,
City
Mashhad
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Masume Masoudian
Street address
Daneshgah Ave.,
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellery for Research and Technology, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Daneshgah Ave.,
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellery for Research and Technology, 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Masume Masoudian
Position
Radiation Oncology Resident
Other areas of specialty/work
Street address
Omid Hospital, Kuhsangi Ave.,
City
Mashhad
Postal code
Phone
+98 51 3842 8621
Fax
Email
MASOUDIANM941@MUMS.AC.IR
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Seyed Amir Aledavood
Position
Assotiate Professor
Other areas of specialty/work
Street address
Omid Hospital, Koohsangi Ave.,
City
Mashhad
Postal code
Phone
+98 51 3842 8621
Fax
Email
ALEDAVOODSA@MUMS.AC.IR
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciecnes
Full name of responsible person
Dr. Masume Masudian
Position
Radiation Oncology Resident
Other areas of specialty/work
Street address
Omid Hospital, Kuhsangi Ave.,
City
Mashhad
Postal code
Phone
+98 51 3509 8885
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)