colo-rectal cancer
Conditions
Interventions
Regorafenib is orally administered daily in one divided doses day 1 to 21 and then 7 days rest.
S-1is orally administered daily in two divided doses day 1 to 28 and then 14 days rest. Bevacizumab is a
Sponsors
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven colon cancer or rectal cancer 2) with measurable lesions for RECIST criteria version 1.1 out of the field of radiation 3) with some unresectable factors 4) older than 20 years 5) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 6) patients with colo-rectal cancer which are resistant or untolerable to fluoropyrimydine, oxaliplatin, irinotecan, anti-VEGF and anti-EGFR. 7) rest period from prior therapy a) more than 4 weeks after surgery resecting some organs b) more than 4 weeks after hormone therapy and/or immune-therapy c) more than 4 weeks after cytokine or BRM therapy d) more than 2 weeks after chemotherapy and /or radiation therapy 8) with good functions of important organs a) WBC: 3,000/mm3<= and 12,000/mm3 > b) Neutrophil: 1,500/mm3<= c) Hemoglobin: 9.0 g/dl <= d) Platelet: 100,000/mm3 <= e) AST, ALT: within 3 times of normal range of the hospital or 5 times if patients have liver metastases f) T.bil.: 1.5 mg/dl> g) creatinine clearance >=50 mL/min male:[(140-age)xB.W.(kg)]/[72x s-creatinine(mg/dl)] female: [(140-age)xB.W.(kg)x0.85]/[72x s-creatinine(mg/dl)] h) urine protein: <= 1+ 9) with written Informed Consent
Exclusion criteria
Exclusion criteria: 1)with active double cancers excluding carcinoma in situ and/or second cancer with over 5 year interval period 2) with uncontrollable diarrhea 3) with difficulty on oral intake due to intestinal paralysis or obstruction 4) with infectious disease or febrile condition 5) with HBs antigen+, HBV-DNA+ (excluding HBs Ab+ and HBV-RNA-, or HBc Ab+ and HBV-DNA-), and/or HCV-RNA+ (excluding HCV Ab+ and HCV-RNA-) 6) with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc) and/or with severe diseases (uncontrollable DM, hypertension, heart failure severer than NYHA III, renal failure and/or hepatic failure) 7) with ascites and/or pulmonary fluids which needs drainage 8) with symptoms due to brain metastasis 9) with metastatic meningitis, uncontrollable convulsion, mental disorder and/or a history of central nerve disorder 10) with a grade 2 neural disorder or mor 11) under treatment with medicine which are contra-indication to Regorafenib, S-1 or Bevacizumab treatment or patients who are contra-indication to Regorafenib, S-1 or Bevacizumab therapy 12) with a history of allergy to Regorafenib, S-1 or Bevacizumab 13) with a history of treatment including Regorafenib, S-1 or Bevacizumab excluding patients with longer than 6 months rest of these treatment 14) with a history of embolism, brain infarction (except Lacuna infarction) or pulmonary infarction 15) under easy bleeding condition due to some diseases or medicines (except low dose aspirin) 16) with a history of thoracic surgery or abdominal surgery within 28 days except CV reservoir 17) with active wounds 18) with a history of bloody spit more than 2.5ml 19) with a grade 2 or more CTCAEv4.0 of prior therapy 20)pregnant or nursing female or male expecting pregnancy of partner 21) Any other patients whom the physician in charge of the study judges to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Response rate Disease control rate Time to treatment failure Advers event | — |
Countries
Japan
Contacts
Public ContactMotoki Yoshida
Osaka Medical College Hospital Chemotherapy Center
Outcome results
None listed