Metastatic clorectal cancer
Conditions
Interventions
A: Fluoropyrimidine (5-FU/LVor capecitabine) + bevacizumab
B: Fluoropyrimidine (5-FU/LV or capecitabine) + oxaliplatin + bevacizumab
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proven colorectal adenocarcinoma. 2) Unresectable stage IV or reccurent colorectal cancer diagnosed by imaging. 3) Age and ECOG PS at registration fulfill either of the following conditions; (1)Age 70-74 and PS 2 (2)Age >= 75 and PS 0-2 4) No obstruction by primary tumor, which can be passed through by an endoscope. 5) No bowel obstruction due to peritoneal dissemination. 6) No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 24 weeks prior to registration. 7) Patients with either measurable or nonmeasurable disease are eligible. 8) No CNS involvement including brain metastasis 9) No prior myeloablative conditioning, whole pelvis irradiation for endometrial cacner, surgery within 12 months and chemotherapy for any malignancies. 10) Adequate organ functions. 11) Peripheral motor or sensory neuropathy =< Grade 1 defined in the CTCAE v4.0. 12) Witten informed consent.
Exclusion criteria
Exclusion criteria: 1) Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 5 years or shoter, except for following;; prostate cancer with clinical stage I and completely resected following cancers; gastric cancer (adenocarcinoma) with stage 0-I, colon cancer (adenocarcinoma) with stage 0-I, esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma) with stage 0, breast cancer (noninvasive ductal carcinoma and noninvasive lobular carcinoma) with stage 0 and breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, and Paget disease) with stage 0-IIA, endometrial cancer (endometrioid adenocarcinoma and mucinous adenocarcinoma) with stage I, prostate cancer (adenocarcinoma) with stae I-II, cervical cancer (squamous cell carcinoma) with stage 0, thyroid cancer (papillary carcinoma and follicular carcinoma) with stage I-III, and renal cancer (clear cell carcinoma and chromophobe cell carcinoma) with stage I. 2) Infectious disease to be treated. 3) Body temparature >= 38c 4) Severe mental disease. 5) Currently treated with systemic steroids 6) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema. 7) Uncontrollable diabetes mellitus or routine administration of insulin. 8) New York Heart Association (NYHA) class III /IV cardiac disease or congestive heart failure that would take medication in order to prevent lethal ventricular arrhythmias. 9) Positive for HBsAg 10) Inadequately controlled hypertension, defined as systolic >= 150 and/or diastolic >= 100 mmHg on anti-hypertensive medications. 11) History of unstable angina, myocardial infarction, pulmonary embolism, deep vein thrombosis, cerebral hemorrhage, cerebral infarction, transient ischemic attack (TIA), cerebrovascular disturbance, or arterial thromboembolism. 12) Known hypersensitivity to any of the component of 5-FU/LV, capecitabine, oxaliplatin, or bevacizumab. 13) Inadequate characteristics for bevacizumab administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Response rate, Adverse events (treatment related death, early death, grade 4 non-hematological toxicities), Quality of Life | — |
Countries
Japan
Contacts
Public ContactTetsuya Hamaguchi
JCOG1018 Coordinating Office Gastrointestinal Medical Oncology, National Cancer Center Hospital
Outcome results
None listed