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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000015320 |
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Date of registration:
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02/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase II study of neoadjuvant chemotherapy with SOX + bevacizumab in patients with locally advanced rectal cancer
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Scientific title:
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Phase II study of neoadjuvant chemotherapy with SOX + bevacizumab in patients with locally advanced rectal cancer - Phase II study of neoadjuvant chemotherapy with SOX + bevacizumab in patients with locally advanced rectal cancer |
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Date of first enrolment:
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2014/04/01 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017434 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hiroyuki Furukawa |
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Address:
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2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
Japan |
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Telephone:
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0166-68-2503 |
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Email:
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f-hiro@asahikawa-med.ac.jp |
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Affiliation:
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Asahikawa Medical University Division of Gastroenterologic and General Surgery |
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Name:
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Masahiro Yamada |
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Address:
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2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
Japan |
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Telephone:
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0166-68-2503 |
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Email:
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ridai@asahikawa-med.ac.jp |
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Affiliation:
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Asahikawa Medical University Division of Gastroenterologic and General Surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Any distant metastases 2) Neurological disorder by cerebrovascular disorder within a year before enrollment 3) Symptomatic heart disease or heart disease requiring treatment. Cardiac infarction within a year before enrollment 4) Pleural, peritoneal and pericardial effusion 5) Prior systematic chemotherapy, pelvic irradiation and/or surgery for malignant tumor 6) Active double cancer. Asynchronous double cancer with disease-free duration of 5 years or less. (Including colorectal cancer) 7) Interstitial pneumonia or pulmonary fibrosis 8) Poorly controlled infection 9) Grade 2 or worse peripheral neuropathy 10) Bowel obstruction (Patients with diverting stoma are allowed for enrollment) 11) Poorly controlled diarrhea 12) Confirmed or possible pregnancy, lactation, willingness to become pregnant (for women), or willingness to have a child (for men) 13) Contraindication of bevacizumab 14) Physician concludes that the patient's participation in this trial is inappropriate.
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Rectal cancer
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Intervention(s)
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SOX+bevacizumab: 3 courses Bevacizumab 7.5mg/kg day1 L-OHP 130mg/m2 day1 S-1 80-120mg/day day1 (after dinner)-15(after breakfast) every 3 weeks SOX: 1 course L-OHP 130mg/m2 day1 S-1 80-120mg/day day1 (after dinner)-15(after breakfast)
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Primary Outcome(s)
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R0 resection rate
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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