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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000001568 |
Receipt No. | R000001888 |
Scientific Title | Phase II trial of neoadjuvant chemotherapy with Bevacizumab plus FOLFOX6 chemotherapy for Resectable case of liver metastasis |
Date of disclosure of the study information | 2008/12/12 |
Last modified on | 2015/03/09 |
Basic information | ||
Public title | Phase II trial of neoadjuvant chemotherapy with Bevacizumab plus FOLFOX6 chemotherapy for Resectable case of liver metastasis | |
Acronym | Before study | |
Scientific Title | Phase II trial of neoadjuvant chemotherapy with Bevacizumab plus FOLFOX6 chemotherapy for Resectable case of liver metastasis | |
Scientific Title:Acronym | Before study | |
Region |
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Condition | ||||||
Condition | synchronous metastatic liver tumors of colorectal cancer | |||||
Classification by specialty |
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Classification by malignancy | Malignancy | |||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Evaluate the feasibility and efficacy of neoadjuvant chemotherapy with Bevacizumab plus FOLFOX6 chemotherapy for resectable case of synchronous liver metastasis from colo-rectal cancer
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Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | response rate |
Key secondary outcomes | safety, R-resection rate
pathological response change of Grading disease free survival progression free survival overall survival |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Neoadjuvant chemotherapy with mFOLFOX6x1, mFOLFOX6+Bevacitumab x 6 and mFOLFOX6x1 followd by resection of origin | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. colorectal cancer diagnosed by histopathology
2. first treatment for measurable synchronous liver metastases. Curative cases by D2 or D3 resection. 3. Enrollment is within 6 weeks after original resection. 4. Written informed consent. 5. Age are from 20 to 74 years old. 6. PS by ECOG is 0 and 1. 7. a life expectancy greater than 3 months. 8. Function of main organ is kept as below, adequate hematologic function (leucocyte count > 3,000/uL, granulocyte count > 1,500/uL, hemoglobin level > 9.0 g/dL, and platelet count > 100,000/uL), adequate renal function (serum creatinine concentration < 1.5). Total bilirubin is within 1.5 times of normal limits. AST and ALT are within 5 times of normal limits. ALP is within 5 times of normal limits. Creatinin is within normal limits. (7) Written informed consent 9. Criteria of operable metastases are below, 1. Within 10 metastases, 2. Liver function is A by Child-Pough classification. 3. Operable case is judged by HBP surgeon. |
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Key exclusion criteria | 1. No extrahepatic lesion
2. No carcinomatous fluid 3. No brain tumor and brain metastases 4. Another cancer with disease free survival within 5 year 5. No cranial nerve and vessel problem, and no past history within 1 year of cranial nerve and vessel problem 6. Operation and incisional biopsy within 2 weeks. Or punctual cytology within 1 week. 7. Thrombosis with present and past history 8. Oral taking with Aspirin and steroid for RA and chronic inflammatory disease 9. Bleeding tendency and clotting abnormality 10. Uncontrollable peptic ulcer disease 11. Perforation of GI tract within 1 year 12. Untreatment of traumatic bone fracture 13. Require treatment of renal dysfunction, or urine protein > +2 within 2 weeks. 14. Uncontrollable hypertension 15. Cardiac disease (over Grade 2 by CTCAE v3.0). Or myocardial infarction within 1 year. 16. No severe anaphylaxis of Leucovorin(LV), 5-Fluorouracil(5-FU) and L-OHP 17. Uncontrollable diarrhea 18. interstitial lung disease, pulmonary fibrosis 19. organ recipient receiving an immunosuppressant 20. Uncontrollable infection 21. pregnant woman, lactating woman, positive of pregnancy test. Or no willing of birth-control 22. case whom principal investigator deny the enrollment. |
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Target sample size | 45 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tohoku University Graduate School of Medicine | ||||||
Division name | Tohoku University Graduate School of Medicine, Division of Hepato-Biliary Pancreatic Surgery | ||||||
Zip code | |||||||
Address | 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN | ||||||
TEL | 022-717-7205 | ||||||
m_unno@surg1.med.tohoku.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Miyagi HBPCOG | ||||||
Division name | Division of Hepato-Biliary Pancreatic Surgery | ||||||
Zip code | |||||||
Address | 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN | ||||||
TEL | 022-717-7205 | ||||||
Homepage URL | |||||||
kein_h11@surg1.med.tohoku.ac.jp |
Sponsor | |
Institute | Miyagi HBPCOG |
Institute | |
Department |
Funding Source | |
Organization | Tohoku University Graduate School of Medicine, Division of Hepato-Biliary Pancreatic Surgery |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001888 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |