A Phase II Study of Capecitabine, Oxaliplatin (XELOX) and Bevacizumab for patient with high-risk Upper Rectal Cancer as Neo-Adjuvant chemotherapy.

A Phase II Study of Capecitabine, Oxaliplatin (XELOX) and Bevacizumab for patient with high-risk Upper Rectal Cancer as Neo-Adjuvant chemotherapy. - COBURA study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015765

Enrollment

Registered

2014-12-01

Start date

2014-11-06

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

Upper rectal cancer

Interventions

XELOX+BEV (4 courses) as neoadjuvant setting. Capecitabine: 2000mg/m2 d1-14 Oxaliplatin: 130mg/m2 d1 Bevacizumab: 7.5mg/kg d1 Q3w (if needed, CRT is applied after completion of neoadjuvant chem

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. Age: 20- years old. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 4. Life expectancy greater than or equal to 3 months 5. Histological confirmation of adenocarcinoma. 6. Site of primary tumor, Rectal (Rs~Ra) cancer. i. TNM ver.7. N2 ii. Japanese classification ver.8., metastasis to lymph node No.252 or No.253. iii. circumferential resection margin <or= 1mm iv. T4 vi. Maximum dimension of tumor >or=80mm vii. Mesorectal fat invasion >or=5mm 7. Vital organ functions (listed below) are preserved within 2 weeks prior to entry. i. Neutrophils>or=1500/mm3 ii. Platelets>or=100,000/mm3 iii. Hemoglobin>or=9.0g/dl iv. AST, ALT and ALP =or<upper limit of normal (ULN)*2.5 v. Total bilirubin =or<upper limit of normal (ULN)*1.5 vi. Serum creatinine =or<upper limit of normal (ULN)*1.5

Exclusion criteria

Exclusion criteria: 1. Malignant coelomic fluid. 2. Multiple primary cancer within 5 years. 3. History of intrapelvic irradiation. 4. Clinically significant complication (heart failure, interstitial lung disease or pulmonary fibrosis, uncontrolled diabetes, renal failure, liver failure, etc.) 5. History of the serious hypersensitivity for any agents. 6. Uncontrolled diarrhea. 7. Evidence of peripheral sensory neuropathy. 8. Uncontrolled Active infection. 9. Other conditions not suitable for this study.

Design outcomes

Primary

Measure	Time frame
R0 resection rate	—

Secondary

Measure	Time frame
Safety (incidence of adverse events), Pathological complete response (pCR), Down-staging rate, Disease-free survival (DFS), local recurrence rate.	—

Countries

Japan

Contacts

Public ContactMitsukuni Suenaga

Cancer Institute Hospital of Japanese Foundation for Cancer Research Gastroenterology

m.suenaga@jfcr.or.jp+81-3-3520-0111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026