Phase II study of combination chemotherapy with S-1 plus Avastin in unresectable or recurrent colorectal cancer after failure of prior chemotherapy, including irinotecan and oxaliplatin regimens.

Phase II study of combination chemotherapy with S-1 plus Avastin in unresectable or recurrent colorectal cancer after failure of prior chemotherapy, including irinotecan and oxaliplatin regimens. - Phase II study of combination chemotherapy with S-1 plus Avastin in unresectable or recurrent colorectal cancer after failure of prior chemotherapy, including irinotecan and oxaliplatin regimens.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002308

Enrollment

Registered

2009-08-07

Start date

2009-07-01

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

colorectal cancer

Interventions

A phase II study of third-line and subsequent treatment with S-1 alone performed in Korea in patients with unresectable, advanced or recurrent colorectal cancer reported a disease control rate of 42.9

s single-stage procedure, we estimated that 35 patients would be required for the study to have a statistical power (1- &amp

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) of 0.80 or higher with a one-sided &amp

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value of 0.05. We assumed that more than 10% of enrolled patients would drop out of the study. The target number of enrolled patients was therefore set at 40.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 20 years to 80 ECOG PS of 0, 1, or 2 Patients who are treated containing irinotecan and oxaliplatin regimes for unresectable or recurrent colorectal cancer. Able to take capsules orally. Adequate function of major organs as defined below: White blood cell count >3,500/mm3, <12,000/mm3 Neutrophil count >1,500/mm3 Hemoglobin >9.0 g/dL Platelet count >100,000/mm3 Total bilirubin <1.5 mg/dL AST and ALT <100 U/L (<200 U/L in patients with liver metastasis) Serum creatinine <1.2 mg/dL Creatinine clearance estimate by the Cockcroft-Gault method >50 mL/min Urine dipstick for proteinuria should be <1+ INR<1.5 Voluntary written informed consent.

Exclusion criteria

Exclusion criteria: Active infections (e.g., patients with pyrexia of 38'C or higher) Continuous treatment with steroids Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes and hypertension) Patients with electrocardiographic abnormalities, with cardiac disorder that would clinically preclude the execution of the study judged by the investigator. Moderate or severe ascites or pleural effusion requiring treatment Active double cancer prior therapy radiotherapy prior therapy S-1 Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children. Serious drug hypersensitivity or a history of drug allergy Treatment with flucytosine Metastasis to the CNS Thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding (Patients who treated low aspirin therapy(<325 mg/day) can be enrolled.) Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks Severe mental disorder Judged ineligible for participation in the study by the investigator for safety reasons.

Design outcomes

Primary

Measure	Time frame
Disease control rate	—

Secondary

Measure	Time frame
Response rate, Progression free survival, Overall survival, frequency of adverese event	—

Countries

Japan

Contacts

Public ContactMotoki Yoshida

Osaka Medical College Hospital Cancer Chemotherapy Center

ctc004@poh.osaka-med.ac.jp072-683-1221

Outcome results

None listed

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