NCT02269904

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

4 years

First QC Date

October 17, 2014

Last Update Submit

October 17, 2014

Conditions

DSF

Outcome Measures

Primary Outcomes (1)

  • DFS (Disease Free Survival)

    During 3 years of monitoring period, any cancer relapse will be recorded

    3 year

Secondary Outcomes (1)

  • adverse event

    3 years

Study Arms (2)

Fluorouracil Implants and Xelox regimes

ACTIVE COMPARATOR

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.

Drug: Fluorouracil ImplantsDrug: Xelox regimes

Xelox regimes

ACTIVE COMPARATOR

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.

Drug: Xelox regimes

Interventions

Fluorouracil ImplantsDRUG

Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation.

Fluorouracil Implants and Xelox regimes
Xelox regimesDRUG

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.

Fluorouracil Implants and Xelox regimesXelox regimes

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary gastric cancer, Phase III
  • D2 radical gastrectomy(R0)
  • 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 .
  • \. the authorized ICF must be signed

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heilongjiang Cancer Hospital

Harebin, Heilongjiang, 150000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34307140DERIVED

Central Study Contacts

Yan Xu, Doctor

CONTACT

13204032770xyab@sina.com

Bo Li, Doctor

CONTACT

13940018765ydyyllwyh2010@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2014

First Posted

October 21, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2018

Study Completion

June 1, 2018

Last Updated

October 21, 2014

Record last verified: 2014-10

Locations

CN(1)