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

NCT ID: NCT02269904

Condition: DSF

Conditions: Official terms:
Stomach Neoplasms
Fluorouracil

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Fluorouracil Implants
Description: Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation.
Arm group label: Fluorouracil Implants and Xelox regimes

Intervention type: Drug
Intervention name: Xelox regimes
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.
Arm group label: Fluorouracil Implants and Xelox regimes
Arm group label: Xelox regimes

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Heilongjiang Cancer Hospital

Address:
City: Harebin
Zip: 150000
Country: China

Status: Recruiting

Contact:
Last name: Chunfeng Li, Doctor

Phone: 18745787187
Email: lichunfeng007@163.com

Investigator:
Last name: Yingwei Xue, Doctor
Email: Principal Investigator

Start date: April 2014

Completion date: June 2018

Lead sponsor:
Agency: Jiangsu Simcere Pharmaceutical Co., Ltd.
Agency class: Industry

Source: Jiangsu Simcere Pharmaceutical Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02269904

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