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Effect of timing of adjuvant chemotherapy on disease-free survival in patients with high-risk stage II and stage III colorectal cancer: A prospective cohort study

Effect of timing of adjuvant chemotherapy on disease-free survival in patients with high-risk stage II and stage III colorectal cancer: A prospective cohort study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119308
Enrollment
Unknown
Registered
2026-02-25
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Colorectal Cancer

Interventions

Spring group:None
Summer group:None
Autumn group:None
Winter group:None

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients must meet all of the following criteria to be enrolled in this study: 1. Age >= 18 years; 2. Histologically confirmed high-risk stage II or stage III colorectal cancer; 3. Underwent radical resection within 12 weeks prior to the first visit; 4. No prior adjuvant chemotherapy; 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2; 6. Adequate bone marrow, liver, and kidney function, defined as follows: (1) Bone marrow function: absolute neutrophil count >= 1.5 × 10?/L, hemoglobin >= 90 g/L, platelet count >= 100 × 10?/L; (2) Liver function: serum total bilirubin = 50 mL/min, and urine dipstick protein < 1+ (unless 24-hour urine protein quantification < 1 g). 7. Capable of understanding the study procedures and willing to provide written informed consent voluntarily.

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria will be excluded from this study: 1. History of other primary malignant tumors; 2. Previous neoadjuvant radiotherapy or chemotherapy for the current diagnosis; 3. History of psychiatric disorders; 4. Currently pregnant; 5. Currently participating in another interventional clinical trial that may interfere with the evaluation of the primary outcome of this study.

Design outcomes

Primary

MeasureTime frame
Disease free survival;

Secondary

MeasureTime frame
Serum 25-hydroxyvitamin D (25(OH)D) level;Serum C-reactive protein (CRP) level;

Countries

China

Contacts

Public ContactQi Shi

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China

stevenshi_qi@hotmail.com+86 180 5878 1451

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026