A phase II study of combination chemotherapy of oral tegafur/uracil, leucovorin and bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer

A phase II study of combination chemotherapy of oral tegafur/uracil, leucovorin and bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer - A phase II study of UFT/LV and bevacizumab treatment

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024330

Enrollment

Registered

2016-10-07

Start date

2016-09-26

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

unresectable metastatic/recurrent colorectal cancer

Interventions

UFT(300mg/m2/day) and LV(75mg/day) are simultaneously given 3times per day for 5days, followed by 2-day rest. Bevacizumab is administerd by every 3 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with histologically verified adenocarcinoma of the colon and rectum 2) Patients with Unresectable metastatic/recurrent colorectal cancer 3) Patients not appropriate for intensive therapy, such as FOLFOX or FOLFIRI 4) Patents without a previous chemotherapy or radiation therapy 5) Patient's age over 20 years-old 6) ECOG Performance status of 0-2 adequate bone marrow, liver, renal, and cardiac function; no prior radiotherapy, chemotherapy or any molecular targeting therapy for rectal cancer; ; no severe concurrent medical or psychiatric illness; no a known hypersensitivity to the study drugs; and none of the patients were pregnant or lactating.

Exclusion criteria

Exclusion criteria: 1)Patients with a past history of severe drug allergy 2)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 3)patients were pregnant or lactating 4)Patients with psychiatric illness 5)Patients with severe co-morbidities (renal failure, liver dysfunction, uncontrolable diabetes mellitus and hypertension, heart failure) 6)Patients with massive ascites or hydrothorax 7)Patients with a symptomatic brain metastasis 8)Patients with abdominal surgery within 28days 9)Patients with perforated disease 10)Patients with thrombosis 11)Patiens with 3+ proteinurea

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Overall survival, Time to treatment failure, Overall response rate, Disease control rate, Adverese	—

Countries

Japan

Contacts

Public ContactKiyoshi Maeda

Osaka City University Graduate School of Medicine Dept 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