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Fluorouracil Implants Used for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer.

Primary Purpose

DSF

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fluorouracil Implants
Xelox regimes
Sponsored by
Jiangsu Simcere Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for DSF

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. primary gastric cancer, Phase III
  2. D2 radical gastrectomy(R0)
  3. 18 year old or above
  4. KPS≥70%；
  5. suitable hematologic function: ANC≥1.5×109/L, PLC≥80×109/L
  6. suitable liver function: Total bilirubin≤1.5×normal ULN, AST and ALT≤2.5×normal ULN.
  7. suitable renal function: Cr≤1.5×normal ULN,or Ccr≥50 ml/min 8 .for the female subject, pregnancy test must be negative in 27 hours before enrollment .

9. the authorized ICF must be signed

Exclusion Criteria:

  1. non-initial gastric cancer；
  2. having the other uncontrolled diseases.
  3. obvious loss of weight ( more than 10% within 6 weeks )
  4. the female in pregnancy or feeding.
  5. contraindication to study drug
  6. participating in other clinical trial and at the time of treatment period.

Sites / Locations

  • Heilongjiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fluorouracil Implants and Xelox regimes

Xelox regimes

Arm Description

Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation. Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished.

Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished.

Outcomes

Primary Outcome Measures

DFS (Disease Free Survival)
During 3 years of monitoring period, any cancer relapse will be recorded

Secondary Outcome Measures

adverse event
During 3 years of monitoring period, any AEs will be recorded

Full Information

First Posted
October 17, 2014
Last Updated
October 17, 2014
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02269904
Brief Title
Fluorouracil Implants Used for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer.
Official Title
Fluorouracil Implants（SinoFuan®）Used for Intraperitoneal Chemotherapy During Operation for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer, Randomized, Controlled, Multicentres Open Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during operation for treatment of gastric cancer. The indication has bee approved by Chinese FDA. The study is a post-marketing study. The subjects will be divided into two groups (Group A and Group B ). The subject in Group A will receive D2 radical gastrectomy(R0),Sinofuan during operation and 6 cycles of Xelox adjuvant chemotherapy.The subject in Group B will receive D2 radical gastrectomy(R0),and 6 cycles of Xelox adjuvant chemotherapy. The subject's benefits from SinoFuan will be analyzed through comparing 3 years DFS of two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DSF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluorouracil Implants and Xelox regimes
Arm Type
Active Comparator
Arm Description
Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation. Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished.
Arm Title
Xelox regimes
Arm Type
Active Comparator
Arm Description
Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished.
Intervention Type
Drug
Intervention Name(s)
Fluorouracil Implants
Intervention Description
Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation.
Intervention Type
Drug
Intervention Name(s)
Xelox regimes
Intervention Description
Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished.
Primary Outcome Measure Information:
Title
DFS (Disease Free Survival)
Description
During 3 years of monitoring period, any cancer relapse will be recorded
Time Frame
3 year
Secondary Outcome Measure Information:
Title
adverse event
Description
During 3 years of monitoring period, any AEs will be recorded
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary gastric cancer, Phase III D2 radical gastrectomy(R0) 18 year old or above KPS≥70%； suitable hematologic function: ANC≥1.5×109/L, PLC≥80×109/L suitable liver function: Total bilirubin≤1.5×normal ULN, AST and ALT≤2.5×normal ULN. suitable renal function: Cr≤1.5×normal ULN,or Ccr≥50 ml/min 8 .for the female subject, pregnancy test must be negative in 27 hours before enrollment . 9. the authorized ICF must be signed Exclusion Criteria: non-initial gastric cancer； having the other uncontrolled diseases. obvious loss of weight ( more than 10% within 6 weeks ) the female in pregnancy or feeding. contraindication to study drug participating in other clinical trial and at the time of treatment period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Xu, Doctor
Phone
13204032770
Email
xyab@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Li, Doctor
Phone
13940018765
Email
ydyyllwyh2010@163.com
Facility Information:
Facility Name
Heilongjiang Cancer Hospital
City
Harebin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunfeng Li, Doctor
Phone
18745787187
Email
lichunfeng007@163.com
First Name & Middle Initial & Last Name & Degree
Yingwei Xue, Doctor

12. IPD Sharing Statement

Citations:
PubMed Identifier
34307140
Citation
Xu Y, Zhang R, Li C, Sun Z, Deng J, Wang X, Ding X, Wang B, Xue Q, Ke B, Zhan H, Liu N, Liu Y, Wang X, Liang H, Xue Y, Xu H. Intraperitoneal Chemotherapy Using Fluorouracil Implants Combined With Radical Resection and Postoperative Adjuvant Chemotherapy for Stage III Gastric Cancer: A Multi-Center, Randomized, Open-Label, Controlled Clinical Study. Front Oncol. 2021 Jul 8;11:670651. doi: 10.3389/fonc.2021.670651. eCollection 2021.
Results Reference
derived

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Fluorouracil Implants Used for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer.

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