A Multicenter Phase II trial of TS-1/oxaliplatin (SOX) +bevacizumab in patients with unresectable advanced/metastatic colorectal cancer (HiSCO-02)

Phase 2

• Conditions: nresectable advanced/metastatic colorectal cancer

• Registration Number: JPRN-UMIN000004976
• Lead Sponsor: Hiroshima Study group of Clinical Oncology (HiSCO)

Brief Summary

PURPOSE:FOLFOX is a standard combination chemotherapy regimen for metastatic colorectal cancer (CRC). 5-Fluorouracil (5-FU) is infused continuously through a pump for 46 h; therefore, replacement of infused 5-FU with oral S-1 would be more convenient for patients. We investigated the efficacy and safety of S-1/oxaliplatin (SOX) plus bevacizumab regimen in a community setting. METHODS:We conducted a phase II clinical study in Hiroshima, Japan. We enrolled individuals aged 20-80 years who had metastatic CRC, an Eastern Cooperative Oncology Group performance status of 0 or 1, assessable lesions, and not received previous chemotherapy. Eligible patients were administered SOX plus bevacizumab (S-1 80 mg/m2/day, day 1-14 orally; and oxaliplatin 130 mg/m2 day 1 i.v., bevacizumab 7.5 mg/kg, day 1 i.v. q3w). The primary endpoint was response rate (RR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. RESULTS:Between May 2011 and January 2014, 55 patients (mean age 64 years) were enrolled at 12 institutions. Median follow up duration was 20.2 months (range 1.3-47.1 months). RR was 47.1 % [95 % confidence interval (CI) 33.7-60.6 %]. Median PFS and OS was 9.2 months (95 % CI 7.6-10.8) and 22.5 months (95 % CI 19.4-25.9), respectively. Major adverse events (grade 3/4) were neutropenia (9.3 %), thrombocytopenia (5.6 %), anorexia (18.5 %), and sensory neuropathy (16.7 %). CONCLUSION:These data suggested that SOX plus bevacizumab is effective and capable of being managed in metastatic CRC patients in our community clinical practice.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

1) History of serious drug hypersensitivity 2) Pregnant or possibly pregnant females, or males with female partners who are planning to pregnancy 3) Severe infectious disease 4) Severe comorbidity (Interstitial lung disease, pulmonary fibrosis, renal failure, liver failure, uncontrollable hypertension, uncontrollable diabetes mellitus, etc) 5) Comorbidity or history of heart failure 6) Evidence of gastrointestinal ulcer or bleeding 7) Peripheral neuropathy 8) Wattery diarrhea 9) Massive pleural effusion or ascites 10) Clinical or radiological evidence of CNS metastases. 11) Current or previous (within the last 6 months) history of GI perforation 12) Previous history of thrombosis or cerebral infarction 13) Any surgical treatments within 28 days 14) Evidence of bleeding diathesis or coagulopathy 15) ongoing treatment with anticoagulant or aspirin (> 325mg/day) 16) Synchronous or metachronous multiple malignancy within the last 5 year disease free interval 17) Previous history of adjuvant chemotherapy with oxaliplatin 18) Under coutinuous steroid administration 19) Any other serious or uncontrolled condition which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial 20) Previous history of hemoptysis 21) Contraindication for administration of L-OHP, BV, TS-1, 5-FU, or l-LV 22) Presence of severe colorectal stricture 23) Radiological evidence of peritoneal dissemination

Study & Design

• Study Type: Interventional
• Study Design: Not specified