Exploratory study to evaluate the recurrence prediction factor in patients with completely resected colorectal cancer which has adjuvant therapy of XELOX.(KPUM-DS-C03)

Exploratory study to evaluate the recurrence prediction factor in patients with completely resected colorectal cancer which has adjuvant therapy of XELOX.(KPUM-DS-C03) - Exploratory study to evaluate the recurrence prediction factor in patients with completely resected colorectal cancer which has adjuvant therapy of XELOX.(KPUM-DS-C03)

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000011459

Enrollment

300

Registered

2013-08-12

Start date

2013-08-12

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Colorectal Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed colorectal cancer 2. High risk stage II or stage III 3. Curability A surgery 4. Age >= 20 years 5. ECOG performance status of 0-1 6. Treatment plan of XElOX adjuvant therapy 7. Adequate organ function 8. Signed written informed consent

Exclusion criteria

Exclusion criteria: 1. Prior oxaliplatin therapy 2. Prior chemotherapy or radiotherapy for colorectal cancer 3. Brain metastasis or active multiple malignancy 4. Peripheral nerve disorder 5. A history of severe drug allergy 6. Active infectious disease 7. Significant mental illness 8. Following complications i) Uncontrolled diabetes ii) Uncontrolled hypertension iii) Interstitial pneumonia iv) Iintestinal tract paralysis or ileus v) Significant heart trouble 9. Inadequate for study enrollment by the physician

Design outcomes

Primary

Measure	Time frame
Correlation of a clinical response and a clinicopathologic factor.	—

Secondary

Measure	Time frame
Correlation of Dose Intensity and Relapse Free Survival. Safety	—

Countries

Japan

Contacts

Public ContactMasayoshi Nakanishi

Kyoto Prefectural University of Medicine Division of Digestive Surgery

mnakan@koto.kpu-m.ac.jp075-251-5527

Outcome results