Randomized Phase III Study of mFOLFOX7 or CAPOX plus Bevacizumab versus 5-Fluorouracil/Leucovorin or Capecitabine plus Bevacizumab as First-line Treatment in Elderly Patients with Metastatic Colorectal Cancer (JCOG1018, RESPECT)

UMIN ID: UMIN000008866

Registered date:06/09/2012

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Metastatic clorectal cancer
• Date of first enrollment: 2012/09/06
• Target sample size: 250
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A: Fluoropyrimidine (5-FU/LVor capecitabine) + bevacizumab
B: Fluoropyrimidine (5-FU/LV or capecitabine) + oxaliplatin + bevacizumab

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: Overall survival, Response rate, Adverse events (treatment related death, early death, grade 4 non-hematological toxicities), Quality of Life

Key inclusion & exclusion criteria

• Age minimum: 70years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Japan Clinical Oncology Group (JCOG)
• Source(s) of Monetary Support: National Cancer Center