Clinical Application of Capecitabine in Maintenance Chemotherapy for Advanced Colorectal Cancer: A Randomized Control Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10000789

Enrollment

Unknown

Registered

2010-02-08

Start date

2010-01-01

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

Recurrent/ Metastatic colorectal cancer

Interventions

Group A:Capecitabine 1g/m2 bid d1-14 q3w

Group B:Observation

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged more than 18 years old; 2. KPS score >=70; 3. Advanced colorectal cancer confirmed by histology or cytology, or irremovable advanced colorectal adenocarcinoma; 4. Patients have received the first-line chemotherapy such as FOLFOX (Oxaliplatin + 5-FU/CF) or XELOX (Capecitabine+ Oxaliplatin) or FOLFIRI (Irinotecan+ 5-FU/CF) or XERILI (Capecitabine+ Oxaliplatin) for 16-24 weeks and reach the complete response, partial response or stable disease according to Response Evaluation Criteria in Solid Tumors; 5. Patients must be enrolled at least 4 weeks after the last radiotherapy and the measurable lesion is not in the radiation scope; 6. Absolute count of Neutrophils >1.5*10^9/L, Platelets count >100*10^9/L, total serum bilirubin 3 months; 8. Signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergic to Capecitabine; 2. Patients received more than 2 Palliative chemotherapy protocols; 3. Patients can not take drugs orally; 4. The cancer has caused cognitive or mental disorder. including the metastases to CNS; 5. Patients have a history of enteritis, chronic diarrhea or recurrent bowel obstruction; 6. Patients with uncontrolled disease in 6 months before enrollment, including unstable angina, acute myocardial infarction, and stroke, et al.; 7. Fertile women who do not take contraception and who are pregnant or lactating; 8. Patients with a carcinoma history before not including basal cell carcinoma or Squamous cell carcinoma of the skin; 9. Other psychological, familial or social factors that affect the compliance.

Design outcomes

Primary

Measure	Time frame
Time to progression;	—

Secondary

Measure	Time frame
Overall survival;Adverse reaction;	—

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