A phase II trial of FOLFOXIRI+Bevacizumab as preoperative chemotherapy for locally advanced lower rectal cancer

A phase II trial of FOLFOXIRI+Bevacizumab as preoperative chemotherapy for locally advanced lower rectal cancer - A phase II trial of FOLFOXIRI+Bev as preoperative chemotherapy for lower rectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031028

Enrollment

Registered

2018-04-01

Start date

2019-03-22

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

Lower rectal cancer

Interventions

Preoperative FOLFOXIRI+Bevacizumab followed by surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pathologically proven adenocarcinoma. 2. Primary tumor located at Ra, Rb or P. The lower margin of the tumor located between Rb and P. 3. cT2N1-3M0 or cT3-4aN0-3M0 tumor 4. With or without lateral pelvic lymph node involvement. 5. Aged beteen 20 and 74 years old 6. Performance status of 0 or 1 7. Sufficient organ function as evidenced by the following laboratory studies within 14 days prior to enrollment 1) WBC count >=3,000 /mm3, <=12,000 /mm3 2) Neutrophil count >= 1,500 /mm3 3) Platelet count >= 100,000 /mm3 4) Hemoglobin >= 8.0 g/dL 5) AST, ALT <= 100 IU/L 6) T.Bil <= 1.5 mg/dL 6) Cr <= 1.5 mg/dL 8. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Previously treated with systemic chemotherapy, radiotherapy, hormone therapy, or immunotherapy for the present disease 2. Severe drug intorelance 3. Peripheral neuropathy (>= Grade 1) 4. Infectious disease to be treated 5. Uncontrollable hypertension 6. Uncontrollable diabetes mellitus 7. Severe heart disease such as congestive heart failure, pectoris, and myocardial infarction. 8. Severe pulmonary disease 9. Severe mental disease 10. Active bleeding from the intestine 11. Currently treated by Phenytoin, Warfarin, or Flucytosine. 12. Diarrhea(>= Grade 2) 13. Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma 14. Women during pregnancy, possible pregnancy or breast-feeding 15. Liver chirrhosis or hepatitis 16. UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 17. Attending physician determines that the case was inappropriate as the subject of this study

Design outcomes

Primary

Measure	Time frame
pathological complete response (pCR) rate	—

Secondary

Measure	Time frame
Feasibility, Response rate, Pathological response rate, Proportion of operative complication, Proportion of adverse events, R0 resection rate, Proportion of anus-preservation, 3 years progression free survival, 3 years overall survival	—

Countries

Japan

Contacts

Public ContactTakeru Matsuda

Kobe University Graduate School of Medicine Department of Surgery, Division of Gastrointestinal Surgery

takerumatsuda@nifty.com078-382-5925

Outcome results

None listed

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