Phase II trial of neoadjuvant chemotherapy with XELOX plus Bevacizumab for locally advanced rectal cancer

Phase II trial of neoadjuvant chemotherapy with XELOX plus Bevacizumab for locally advanced rectal cancer - N-SOG 03

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003507

Enrollment

Registered

2010-04-20

Start date

2010-02-01

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

Locally advanced rectal cancer

Interventions

Neoadjuvant chemotherapy with XELOX plus Bevacizumab followed by surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Writen informed consent 2.Histologically proven adenocarcinoma of the rectum 3. Clinical confirmed locally advanced rectal cancer 4. Without distant metastases (M0) 5. Age: 20-80 years 6. Performance status (PS) 0-1 7. Alife expectancy greater than 12 weeks 8. Without prior radiotherapy for the pelvis 9. Adequate organ function

Exclusion criteria

Exclusion criteria: 1. Multiple malignacies to be treated 2. Uncontrollable peptic ulcer disease 3. Serious complications 4. Previous history of severe drug-induced allergy 5. Severe neuropathy 6. With interstitial lung disease or pulmonary fibrosis 7. Pregnant 8. Prior chemotherapy with bevacizumab, oxaliplatin or capecitabin 9. Disqualified by attending docor

Design outcomes

Primary

Measure	Time frame
Treatment compliance	—

Secondary

Measure	Time frame
Overall survival, disease free survival, local recurrence rate, response 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