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Phase II Trial of Preoperative Chemoradiation in Patients With Localized Gastric Cancer (LAGCCS001): To Increase the Chance of Radical Surgery

Phase II Trial of Preoperative Chemoradiation in Patients With Localized Gastric Cancer (LAGCCS001): To Increase the Chance of Radical Surgery

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-12002222
Enrollment
Unknown
Registered
2012-05-24
Start date
2012-04-09
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 Cancer

Interventions

1:Preoperative Chemoradiation

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged to be 18 to 70, Male or Female; 2. Minimum life expectancy of 6 months; 3. Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma; 4. Patients must have a performance status of 1,500/uL, and platelet count of > 100,000/uL), adequate liver function (bilirubin <= 1.5 mg/dl), and adequate renal function (creatinine <= 1.5 mg/dl); 11. Patients without cardiac disease, severe uncontrolled diabetes, hypertension, cerebrovascular disease, or infection.

Exclusion criteria

Exclusion criteria: 1. Pregnant women are excluded from study entry due to the potential teratogenic effects of the study treatment; 2. Female patients who planed to have a baby; 3. Prior radiation therapy to the stomach, liver or kidney; 4. Dysfunction of important organs such as liver, kidney or heart; 5. Abnormalities of mental status; 6. Active coronary artery disease; 7. Cardiac arrhythmia, and need to receive medication therapy; 8. Severe uncontrolled hypertension; 9. Active clinical serious infection; 10. The known human immunodeficiency virus (HIV) infection history; 11. The known central nervous system diseases, including brain metastatic tumors; 12. Patients have had clinical clear gastrointestinal bleeding in 6 months; 13. Drug abuse; 14. Swallowing difficulties for drugs; 15. Poor compliance; 16)Presence of concurrent or previous malignancies (except for cervical carcinoma in situ or basal cell carcinoma of the skin); 17. Presence of peritoneal metastasis, distant organs or lymph nodes metastasis; 18. Presence history of major surgy in the past three months; 19. Poor tolerability; 20. Prior history of medication; 21. allergy for chemotherapeutic drugs.

Design outcomes

Primary

MeasureTime frame
R0 resection rate;

Secondary

MeasureTime frame
pCR;DFS;

Countries

China

Contacts

Public ContactYanong Wang
wangyn1111@hotmail.com+86 13801802720

Outcome results

None listed

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