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Perioperative Chemotherapy for Potentially Resectable Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin
Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin
Oxaliplatin; Capecitabine
Sponsored by
Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Tegafur，Gimeracil and Oteracil Potassium Capsules, Capecitabine, Oxaliplatin, perioperative Chemotherapy, Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 -75
  • Histologically or cytologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction)
  • ECOG performance status ≦2
  • Tumor stage T3/4NxM0
  • No distant metastasis (M0)

Exclusion Criteria:

  • History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
  • Inadequate hematopoietic function： WBC≦4,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3
  • Inadequate organ function which is defined as below:

Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 1.2 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);

  • Symptomatic peripheral neuropathy
  • Receiving a concomitant treatment with other fluoropyrimidines
  • Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method.
  • Mental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication:
  • Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study.
  • History of ventricular arrhythmia or congestive heart failure.
  • Significant co-morbid medical conditions, including, but not limited to, Chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary fibrosis, heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes.

Sites / Locations

  • Department of General Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

postoperative chemotherapy,SOX

Perioperative chemotherapy,SOX

Perioperative chemotherapy,XELOX

Arm Description

Outcomes

Primary Outcome Measures

Disease-free survival(DFS)

Secondary Outcome Measures

Objective response rate (ORR)
Disease control rate (DCR)
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
Down staging rate
After the pathological examination of resected specimen
Overall survival (OS)
Adverse events
Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit.
R0-resection rate
After the pathological examination of resected specimen

Full Information

First Posted
January 10, 2012
Last Updated
February 11, 2020
Sponsor
Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01516944
Brief Title
Perioperative Chemotherapy for Potentially Resectable Gastric Cancer
Official Title
Perioperative Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin Versus Capecitabine Plus Oxaliplatin in Patients With Localized Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Stage I：Neoadjuvant therapy Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to surgery alone;Capecitabine plus oxaliplatin is non-inferiority to Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin Stage II: Perioperative therapy Perioperative Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to adjuvant Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin alone;Capecitabine plus oxaliplatin regimen is noninferiority to Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin A regimen of Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin(SOX) and Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic gastric cancer. The investigators assessed whether the addition of a perioperative regimen of SOX or XELOX regimen to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced gastric cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Tegafur，Gimeracil and Oteracil Potassium Capsules, Capecitabine, Oxaliplatin, perioperative Chemotherapy, Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
749 (Actual)

8. Arms, Groups, and Interventions

Arm Title
postoperative chemotherapy,SOX
Arm Type
Active Comparator
Arm Title
Perioperative chemotherapy,SOX
Arm Type
Experimental
Arm Title
Perioperative chemotherapy,XELOX
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin
Other Intervention Name(s)
S-1, Oxaliplatin
Intervention Description
Tegafur，Gimeracil and Oteracil Potassium Capsules 80 mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation
Intervention Type
Drug
Intervention Name(s)
Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin
Other Intervention Name(s)
S-1, Oxaliplatin
Intervention Description
Tegafur，Gimeracil and Oteracil Potassium Capsules 80mg/㎡ ,D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycles preoperation, Tegafur，Gimeracil and Oteracil Potassium Capsules ,80 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for six cycles postoperation
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin; Capecitabine
Other Intervention Name(s)
Oxaliplatin, Capecitabine
Intervention Description
Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycle pre-operation, Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/m2 D1 q3wk for six cycles postoperation
Primary Outcome Measure Information:
Title
Disease-free survival(DFS)
Time Frame
3 year
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Time Frame
At the end of the study
Title
Disease control rate (DCR)
Description
To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria
Time Frame
At the end of the study
Title
Down staging rate
Description
After the pathological examination of resected specimen
Time Frame
Within 3 weeks after surgery
Title
Overall survival (OS)
Time Frame
5 year
Title
Adverse events
Description
Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit.
Time Frame
Side effects during observation
Title
R0-resection rate
Description
After the pathological examination of resected specimen
Time Frame
Within 3 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 -75 Histologically or cytologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) ECOG performance status ≦2 Tumor stage T3/4NxM0 No distant metastasis (M0) Exclusion Criteria: History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product Inadequate hematopoietic function： WBC≦4,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3 Inadequate organ function which is defined as below: Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 1.2 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation); Symptomatic peripheral neuropathy Receiving a concomitant treatment with other fluoropyrimidines Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method. Mental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication: Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study. History of ventricular arrhythmia or congestive heart failure. Significant co-morbid medical conditions, including, but not limited to, Chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary fibrosis, heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qun Zhao, Doctor
Organizational Affiliation
Hebei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General Surgery
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
32583567
Citation
Zhao Q, Lian C, Huo Z, Li M, Liu Y, Fan L, Tan B, Zhao X, Zhang Z, Wang D, Liu Y, Guo H, Yang P, Tian Y, Li Y. The efficacy and safety of neoadjuvant chemotherapy on patients with advanced gastric cancer: A multicenter randomized clinical trial. Cancer Med. 2020 Aug;9(16):5731-5745. doi: 10.1002/cam4.3224. Epub 2020 Jun 24.
Results Reference
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Perioperative Chemotherapy for Potentially Resectable Gastric Cancer

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