A multi-center clinical trail for Tegafur, gimeracil and oteracil potassium capsules combined with Oxaliplatin in treatment of phase II, IIIa gastric cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001560

Enrollment

Unknown

Registered

2011-09-09

Start date

2011-10-01

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 cancer

Interventions

A:Tegafur, Gimeracil and Oteracil Potassium Capsules 40 mg/m2, B.i.d P.O.

Oxaliplatin 130 mg/m2, d1-14, integrated in 5% GS 250 ml, ivgtt 120/min

repeated every 3 weeks

B:Tegafur, Gimeracil and Oteracil Potassium Capsules 40 mg/m2, B.i.d ,P.O., d1-14

repeated evey 3 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: To be enrolled each of the following criteria should be met: 1) To be aged >=18years; 2) ECOG: 0-1 points; 3) Patients with phase II, IIIa gastric cancer and accepted D2 radical surgery in last 6 weeks, in additional without gross or microscopic residual tumor; 4) Predictive life span > 12 weeks; 5) Patients without systemic chemotherapy and radiotherapy previosly; 6) Patients without major organ dysfunction, heart function, kindey function, liver function are normal, Biochemistry indx: Blood: WBC>4.0*10^9/L, N>50-70%, PLT>100*10^9/L, Hb>11g/dl; Liver function: serumbilirubin<1.5 times of the normal cap; ALT < 1.5 timesof the normal cap; AST< 1.5 times the normal cap; BUN, Cr are in normal; 7) Patients comprehend this trail and signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with pathomorphological classification and clinical stages which can not meet the inclusion criteria; 2) Patients with systemic chemotherapy or Sorafenib previously; 3) Patients with serious complication, heart dysfunction, liver dysfunction, kindey dysfunction, lungs dysfunction or insufficiency of marrow function; 4) A patient with serious cardiovascular disease in past 12 months including: intractable hypertention; unstable angina; myocardial infarction; uncontrolled arrhythmia; congestive heart-failure >=NYHA 2; 5) Patients with neoplasm metastasis; 6) A patient with uncontrolled serious infection diseases, or serious metabolic disease; 7) Patients with biological agents allergy history, allergic constitution or is in a state of allergy; 8) Patients with poor compliance unwilling or unable to comply with the provisions of the study, patients can not finish follow-up; 9) Patients inappropriate for this trail; 10) Patients without informed consent.

Design outcomes

Primary

Measure	Time frame
Recurrence free survival, RFS;	—

Secondary

Measure	Time frame
Overall Survival;	—

Countries

China

Contacts

Public ContactHua Yawei, Wang Jufeng

hnzzwjf@yahoo.com.cn+86 0371 65587625

Outcome results

None listed

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