The effect of total neoadjuvant multidrug chemotherapy including fluorouracil, leucovorin, oxaliplatin and docetaxel on pathologic complete response resectable locally advanced gastric adenocarcinoma
To determine the complete pathologic response rate following complete neoadjuvant chemotherapy in patients with resectable locally advanced gastric adenocarcinoma
Design
Phase 2 single group clinical trial without blinding, without randomization and without parallel group on 63 patients.
Settings and conduct
This single arm clinical trial will be performed in the oncology radiotherapy ward of Namazi Hospital. In this study, patients with operable gasteric cacner will be assigned to the intervention grout to receive complete neoadjuvant chemotherapy.
Participants/Inclusion and exclusion criteria
In this single arm study, patients with pathologically confirmed gastric adenocarcinoma in biopsy, perigastric lymph node metastasis in CT scan and resectable primary gastric tumor based on CT scan and main exclusion criteria are no distant metastasis at the presentation, previous history of chemotherapy, previous history of radiotherapy. previous history of malignancy, suffering from uncontrolled diabetes mellitus and uncontrolled hypertension and no consent to enroll
Intervention groups
Patients will be treated with complete neoadjuvant chemotherapy.
Main outcome variables
Pathological response, surgical margin status and treatment side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211211053356N1
Registration date:2022-01-21, 1400/11/01
Registration timing:registered_while_recruiting
Last update:2022-01-21, 1400/11/01
Update count:0
Registration date
2022-01-21, 1400/11/01
Registrant information
Name
Mehrdad Golmoradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4332
Email address
mehrdadg239@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of total neoadjuvant multidrug chemotherapy including fluorouracil, leucovorin, oxaliplatin and docetaxel on pathologic complete response resectable locally advanced gastric adenocarcinoma
Public title
Total neoadjuvant multidrug chemotherapy in the management of gastric cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pathologically confirmed gastric adenocarcinoma in biopsy
Perigastric lymph node metastasis in CT scan
Resectable primary gastric tumor based on CT scan
Exclusion criteria:
Presence of distant metastasis at the presentation
Previous history of chemotherapy
Previous history of radiotherapy
Previous history of malignancy
Suffering from uncontrolled diabetes mellitus
Suffering from uncontrolled hypertension
No consent to enroll
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
63
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
Research Ethics Committees of School of Medicine - Shiraz University of Medical Sciences
Street address
Zand St., Imam Hossein Sq., Shiraz Medical School
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2021-08-19, 1400/05/28
Ethics committee reference number
IR.SUMS.MED.REC.1400.264
Health conditions studied
1
Description of health condition studied
Gastric cancer
ICD-10 code
C16.9
ICD-10 code description
Malignant neoplasm of stomach, unspecified
Primary outcomes
1
Description
Pathologic response
Timepoint
After the intervention and providing the pathologic report of gastrectomy
Method of measurement
Based on report of pathologist
Secondary outcomes
1
Description
Surgical margin status
Timepoint
After the intervention and providing the pathologic report of gastrectomy
Method of measurement
Based on pathologist report
2
Description
Treatment completion rate
Timepoint
During the intervention, every three week
Method of measurement
History taking
3
Description
Treatment toxicity
Timepoint
During the intervention, every three week
Method of measurement
history taking
Intervention groups
1
Description
Intervention group: In total neoadjuvant chemotherapy group, patients will be treated with eight sessions of fluorouracil, leucovorin, oxaliplatin, and docetaxel before surgery. Fluorouracil as a 24-hour intravenous infusion at a dose of 2600 mg per body surface area on the first day, leucovorin as a 1-hour intravenous infusion at a dose of 200 mg per body surface area on the first day, oxaliplatin as a 1-hour intravenous infusion at a dose of 85 mg per body surface area on the first day and docetaxel as a 2-hour intravenous infusion at a dose of 50 mg per body surface area on the first day will be administered. Chemotherapy will be performed every 2 weeks in 8 sessions.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Mansour Ansari
Street address
Zand Street, Namazi Square
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
nemazee_inf@sums.ac.ir
Web page address
https://namazi.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Street address
Zand St., the central building of Shiraz University of Medical Sciences, the seventh floor
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
https://research.sums.ac.ir/Page-ResearchM/fa/205
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?