Fluorouracil versus Fluorouracil plus Sporam for patients with Stage II Colorectal Cancer after Surgery

A Randomized Clinical Trial Comparing 5-FU alone Versus 5-FU+Sporam for Patients With Stage II Colorectal Cancer after Surgery

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10000936

Enrollment

Unknown

Registered

2010-06-25

Start date

2010-08-01

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

colorectal cancer

Interventions

5-FU:intravenous infusion of 5-FU at a dosage of 450 mg

5-FU+Sporamin:intravenous infusion of 5-FU at a dosage of 450 mg

Eligibility

Sex/Gender

All

Age

20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of stage II colorectal cancer (histologically confirmed stage II disease (T3-4, N0, M0)); 2. Has just performed the complete resection, no residual tumor; 3. No prior radiotherapy, chemotherapy or immunotherapy; 4. No other serious complications or malignant disease; 5. With normal hematopoietic and liver function

Exclusion criteria

Exclusion criteria: 1. Hematopoietic, liver and kidney dysfunction; 2. With other serious complications or malignant diseases; 3. Has undergone surgical resection of the tumor for more than 40 days

Design outcomes

Primary

Measure	Time frame
Blood biochemical parameter;	—

Secondary

Measure	Time frame
Faecal markers;Medical Symptoms and Signs of the Disease;	—

Countries

China

Contacts

Public ContactTai-Hua Mu

mutaihua@126.com+86 010 62815541

Outcome results

None listed

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