Unique ID issued by UMIN | UMIN000015765 |
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Receipt number | R000018296 |
Scientific Title | A Phase II Study of Capecitabine, Oxaliplatin (XELOX) and Bevacizumab for patient with high-risk Upper Rectal Cancer as Neo-Adjuvant chemotherapy. |
Date of disclosure of the study information | 2014/12/01 |
Last modified on | 2020/06/01 20:28:53 |
A Phase II Study of Capecitabine, Oxaliplatin (XELOX) and Bevacizumab for patient with high-risk Upper Rectal Cancer as Neo-Adjuvant chemotherapy.
COBURA study
A Phase II Study of Capecitabine, Oxaliplatin (XELOX) and Bevacizumab for patient with high-risk Upper Rectal Cancer as Neo-Adjuvant chemotherapy.
COBURA study
Japan |
Upper rectal cancer
Gastroenterology | Gastrointestinal surgery | Radiology |
Malignancy
NO
To evaluate the safety and efficacy of neoadjuvant XELOX plus Bevacizumab for high-risk advanced upper rectal cancer.
Safety,Efficacy
R0 resection rate
Safety (incidence of adverse events), Pathological complete response (pCR), Down-staging rate, Disease-free survival (DFS), local recurrence rate.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
XELOX+BEV (4 courses) as neoadjuvant setting.
Capecitabine: 2000mg/m2 d1-14
Oxaliplatin: 130mg/m2 d1
Bevacizumab: 7.5mg/kg d1
Q3w
(if needed, CRT is applied after completion of neoadjuvant chemotherapy)
20 | years-old | <= |
Not applicable |
Male and Female
1. Written informed consent
2. Age: 20- years old.
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
4. Life expectancy greater than or equal to 3 months
5. Histological confirmation of adenocarcinoma.
6. Site of primary tumor, Rectal (Rs~Ra) cancer.
i. TNM ver.7. N2
ii. Japanese classification ver.8., metastasis to lymph node No.252 or No.253.
iii. circumferential resection margin <or= 1mm
iv. T4
vi. Maximum dimension of tumor >or=80mm
vii. Mesorectal fat invasion >or=5mm
7. Vital organ functions (listed below) are preserved within 2 weeks prior to entry.
i. Neutrophils>or=1500/mm3
ii. Platelets>or=100,000/mm3
iii. Hemoglobin>or=9.0g/dl
iv. AST, ALT and ALP =or<upper limit of normal (ULN)*2.5
v. Total bilirubin =or<upper limit of normal (ULN)*1.5
vi. Serum creatinine =or<upper limit of normal (ULN)*1.5
1. Malignant coelomic fluid.
2. Multiple primary cancer within 5 years.
3. History of intrapelvic irradiation.
4. Clinically significant complication (heart failure, interstitial lung disease or pulmonary fibrosis, uncontrolled diabetes, renal failure, liver failure, etc.)
5. History of the serious hypersensitivity for any agents.
6. Uncontrolled diarrhea.
7. Evidence of peripheral sensory neuropathy.
8. Uncontrolled Active infection.
9. Other conditions not suitable for this study.
40
1st name | Takashi |
Middle name | |
Last name | Akiyoshi |
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Gastroenterological Surgery
135-8550
3-8-31, Ariake, Koto-ku, Tokyo
+81-3-3520-0111
takashi.akiyoshi@jfcr.or.jp
1st name | Mitsukuni |
Middle name | |
Last name | Suenaga |
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Gastroenterology
135-8550
3-8-31, Ariake, Koto-ku, Tokyo
+81-3-3520-0111
m.suenaga@jfcr.or.jp
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Japanese Foundation for Cancer Research
Other
IRB of the Cancer Institute Hospital of JFCR
3-8-31, Ariake, Koto-ku, Tokyo, Japan
+81-3-3520-0111
med.shinsa@jfcr.or.jp
NO
2014 | Year | 12 | Month | 01 | Day |
Unpublished
19
Terminated
2014 | Year | 02 | Month | 06 | Day |
2014 | Year | 07 | Month | 23 | Day |
2014 | Year | 11 | Month | 06 | Day |
2020 | Year | 06 | Month | 30 | Day |
2014 | Year | 11 | Month | 27 | Day |
2020 | Year | 06 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018296
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