COX-2 alteration in advanced colon cancer treated with capecitabine versus 5-fluorouracil and calcium folinate (Mayo regimen) combination

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003646-34-LT

Enrollment

Registered

2005-08-03

Start date

2005-10-10

Completion date

Unknown

Last updated

2013-03-25

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

Conditions

III stage (Dukes' stage) colon cancer patients who underwent surgery

Interventions

Trade Name: Xeloda Product Name: Xeloda Pharmaceutical Form: Coated tablet INN or Proposed INN: capecitabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -age>18 -signed written informed consent -histologically and cytologically confirmed colon carcinoma -III stage (Dukes' stage) colon cancer patients after surgery. No evidence of distal metastasis -indicated adjuvant treatment -no evidence of other diseases or conditions giving reasonable suspicion of high risk exacerbation or adjuvant treatment complications (i.e. myocardial infarction, stroke, unstable angina for the last 6 months) -adequate liver and kidney function -adequate bone marrow function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -known other active tumors (except basal carcinoma of skin, in-situ carcinoma of the cervix -known DPD (dihydropyrimidine dehydrogenase) deficit -metastatic colon cancer -permanent use of NSAIDs -known sensitivity to fluoropyrimidine and it’s metabolites -pregnant or lacting women -performed nonradical surgery -CRP>20mg/l, increased amount of a2, ?.

Design outcomes

Primary

Measure	Time frame
Main Objective: - to assess and to compare alteration of COX-2 ferment concentration in plasma of III stage (Dukes' stage) colon cancer patients who underwent surgery and received adjuvant treatment with capecitabine versus standard Mayo regimen.;Secondary Objective: - to evaluate safety and toxicity of capecitabine in nonmetastatic colon cancer patientsversus standard Mayo regimen; - to evaluate alternation of COX-2 ferment concentration and impact on early relapse in patients treated with capecitabine versus standard Mayo regimen. ;Primary end point(s): - assessment of COX-2 ferment concentration in plasma before chemotherapy, 3 weeks after third or just before fourth cycle and not earlier than 3 weeks, but not later than 6 weeks after chemotherapy - adverse reactions	—

Measure

Time frame

Main Objective: - to assess and to compare alteration of COX-2 ferment concentration in plasma of III stage (Dukes' stage) colon cancer patients who underwent surgery and received adjuvant treatment with capecitabine versus standard Mayo regimen.;Secondary Objective: - to evaluate safety and toxicity of capecitabine in nonmetastatic colon cancer patientsversus standard Mayo regimen; - to evaluate alternation of COX-2 ferment concentration and impact on early relapse in patients treated with capecitabine versus standard Mayo regimen. ;Primary end point(s): - assessment of COX-2 ferment concentration in plasma before chemotherapy, 3 weeks after third or just before fourth cycle and not earlier than 3 weeks, but not later than 6 weeks after chemotherapy - adverse reactions

—

Countries

Lithuania

Outcome results

None listed

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