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Fluorouracil Sustained Release for implant for prevention of relapse and metastasis of gastric adenocarcinoma

Fluorouracil Sustained Release for implant for prevention of relapse and metastasis of gastric adenocarcinoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000264
Enrollment
Unknown
Registered
2008-12-19
Start date
2006-09-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric adenocarcinoma (progressive stage)

Interventions

Group A:Standard D2 gastric carcinoma radical resection+ 800mg Fluorouracil Sustained Release for implant+ Standard Postoperative chemotherapy
Group B:Standard D2 gastric carcinoma radical resection+ Irrigation of peritoneal cavity with 5-FU 500mg/m2+ Standard Postoperative chemotherapy

Sponsors

Ruijin Hospital affiliated to Shanghai Jiaotong University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Gastric adenocarcinoma confirmed by pathology. Progressive stage was comfirmed by gastric endoscope or CT or endoscopic ultrasonography; 2. Aged 18-75 years old; 3. Expectant survival >12 months; 4. Blood cell counts results are normal and no severe heart, lung, liver and kidney dysfunction; 5. No jaundice, ascites or GI obstruction; 6. Karnofsky score >=80; 7. Patients who voluntarily signed the informed consent form and agreed to receive standard postoperative adjunctive chemotherapy and follow-up designed by the trial.

Exclusion criteria

Exclusion criteria: 1. The gastric adenocarcinoma is in rapid progression stage; 2. Patients participated in other similar clinical drug trials in last two months since screening; 3. Pregnant or lactated women; 4. Patients have acute infection; 5. Patients with gastric cancer (Early Stage); 6. Patients have severe cardiovascular disease or psychiatric disease.

Design outcomes

Primary

MeasureTime frame
Tumor-free survival time;Postoperative survival time;

Countries

China

Contacts

Public ContactZhenggang Zhu
jun_zj0977@yahoo.com.cn+86 021 64370045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026