Phase II trial of neoadjuvant chemotherapy with mFOLFOX6 plus Bevacizumab for resectable local recurrent rectal cancer

Phase II trial of neoadjuvant chemotherapy with mFOLFOX6 plus Bevacizumab for resectable local recurrent rectal cancer - N-SOG 02

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002920

Enrollment

Registered

2009-12-21

Start date

2009-12-01

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

Resectable local recurrent rectal cancer

Interventions

Neoadjuvant chemotherapy with mFOLFOX6 plus bevacizumab followed by surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Clinical confirmed local recurrent rectal cancer i. resectable ii. need for combined resection of adjacent organs or structures iii. without extra-pelvic metastases 2. Without prior chemotherapy with oxaliplatin or bevacizumab 3. Performance status (PS) 0-1 4. Age: 20-74 years 5. Alife expectancy greater than 12 weeks 6. Adequate organ function 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Unresectable local recurrent rectal cancer 2. Active infections 3. With brain metastases 4. Severe neuropathy 5. Pregnant 6. Prebious history of severe drug-induced allergy 7. Serious complications 8. With interstitial lung disease or pulmonary fibrosis 9. Multiple malignancies to be treated 10. Uncontrollable peptic ulcer disease 11. Disqualified by attending doctor

Design outcomes

Primary

Measure	Time frame
disease free survival	—

Secondary

Measure	Time frame
overall survival, R0 resection rate	—

Countries

Japan

Contacts

Public ContactKeisuke Uehara

Nagoya University Graduate School of Medicine Division of Surgical Oncology

kuehara@med.nagoya-u.ac.jp

Outcome results

None listed

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