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Phase II study of neoadjuvant bevacizumab with weekday-on/weekday-off capecitabine and radiation for locally advanced rectal cancer

Phase II study of neoadjuvant bevacizumab with weekday-on/weekday-off capecitabine and radiation for locally advanced rectal cancer - Neoadjuvant bevacizumab with capecitabine and radiatiotherapy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011365
Enrollment
27
Registered
2013-08-03
Start date
2013-04-22
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

rectal cancer

Interventions

neoadjuvant chemoradiotherapy

Sponsors

Osaka City University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligible patients had to have a histologically verified adenocarcinoma of the rectum with the inferior margin within 5cm from the anal verge, as assessed by rectosigmoidoscopy. The tumor had to have evidence of T3/T4 disease or any T disease with positive locoregional lymphnodes detected by computed tomography (CT) and magnetic resonance imaging (MRI) of the pelvis. The disease was considered to be resectable at the time of entry in all cases, with no evidence of distant metastases.

Exclusion criteria

Exclusion criteria: prior radiotherapy, chemotherapy or any molecular targeting therapy for rectal cancer; no other co-existing malignancy or malignancy within the last five years prior to enrollment other than non-melanoma skin cancer or in situ carcinoma of the cervix; no severe concurrent medical or psychiatric illness; no a known hypersensitivity to the study drugs; and none of the patients were pregnant or lactating.

Design outcomes

Primary

MeasureTime frame
pCR rate

Secondary

MeasureTime frame
response rate,rate of R0 resection, 3-years survival rate

Countries

Japan

Contacts

Public ContactKiyoshi Maeda

Osaka City University Hospital Department of Surgical Oncology

m1378386@med.osaka-cu.ac.jp06-6645-3838

Outcome results

None listed

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