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Phase II study of gimeracil and oteracil porassium capsules combined with calcium folinate and oxaliplatin(SOL) on advanced-stage colorectal carcinoma

Phase II study of gimeracil and oteracil porassium capsules combined with calcium folinate and oxaliplatin(SOL) on advanced-stage colorectal carcinoma

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TNRC-10000838
Enrollment
Unknown
Registered
2010-04-08
Start date
2010-03-01
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

Advanced-stage colorectal carcinoma

Interventions

Total:S1:BSA=1.25 m2,=1.25 m2,=1.5 m2, 60 mg*2/day)* 7days
calcium folinate: 25 mg*2/day*7days
oxaliplatin: 85 mg/m2 iv.in 3 hours * 1 day. Repeat every 2 weeks

Sponsors

Sun Yat-Sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 20 Years

Inclusion criteria

Inclusion criteria: 1. Age>20 years; 2. Tolerant to oral administration; 3. Pathological diagnosis of colorectal carcinoma; 4. With the informed consent signed by the patient; 5. No previous treatment (radiotherapy, chemotherapy, immunotherapy, et al); or recovery in 180 days after adjuvant chemotherapy without L-OHP; or recovery in i year after adjuvant chemotherapy with L-OHP; 6. Focus >1cm detected by CT or MRI15 days before; 7. Renal and liver function fits the condition as follows: hemoglobulin >90g/L, WBC 4.0*10^9/L-12.0*10^9/L, neutrophil >2.08*10^9/L, platelet >100*10^9/L, total bilirubin 90 days.

Exclusion criteria

Exclusion criteria: 1. Seriously allergic to platinum 5-FU?FT?LV and 5-HT3 receptor antagonists; 2. Participated in other trials 4 weeks before; 3. Received the operation treatment 4 weeks before; 4. Diarrhea; 5. Active infection (fever>38 degree C); 6. Complicated with poor-controlled hypercalcinemia, hypertension and diabetes; 7. Complicated with cardiac diseases (cardiac dysfunction, myocardial infarction and angina) and abnormal ECG; 8. Complicated with serious pulmonary disease (interstitial pneumonia, pulmonary fibrosis, emphysema); 9. Past history of the mental disorders and central nervous system disorders which affect the treatment; 10. Complicated with active hemorrhage of digestive tract; 11. With pleural, abdominal and pericardial effusion; 12. Complicated with multiple osseous metastasis; 13. Complicated with severe intestinal obstruction, renal failure, liver failure and cerebrovascular disease; 14. With cerebral metastasis; 15. With several active cancers; 16. Pregnant or breast-feeding women; 17. Other situations unsuited for the trial.

Design outcomes

Primary

MeasureTime frame
Objective response rate;Progression-free survival;

Secondary

MeasureTime frame
Adverse event;Time to treatment failure;Overall survival time;

Countries

China

Contacts

Public ContactRuihua Xu
xurh@sysucc.org.cn+86 020 87343356

Outcome results

None listed

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