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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000031626 |
Receipt No. | R000036106 |
Scientific Title | Phase II study of surgery after S-1 + oxaliplatin + bevacizumab therapy for unresectable rectal cancer by organ-preserved TME |
Date of disclosure of the study information | 2018/03/08 |
Last modified on | 2019/09/08 |
Basic information | ||
Public title | Phase II study of surgery after S-1 + oxaliplatin + bevacizumab therapy for unresectable rectal cancer by organ-preserved TME | |
Acronym | Surgery after SOX+Bmab for unresectable rectal cancer by organ-preserved TME | |
Scientific Title | Phase II study of surgery after S-1 + oxaliplatin + bevacizumab therapy for unresectable rectal cancer by organ-preserved TME | |
Scientific Title:Acronym | Surgery after SOX+Bmab for unresectable rectal cancer by organ-preserved TME | |
Region |
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Condition | ||
Condition | Unresectable rectal cancer by organ-preserved TME | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The objective of this study was to examine the efficacy and safety of surgery after S-1 + oxaliplatin + bevacizumab therapy for unresectable rectal cancer by organ-preserved TME |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | T down-staging rate |
Key secondary outcomes |
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 | S-1 is administered orally at 80mg/m2/day for 14 consecuitive days followed by a 7 day rest. L-OHP is given intravenously on days 1, at a dose of 130mg/m2/day.Bevacizumab is given intravenously on days 1, at a dose of 7.5mg/kg/day. 21 days are assumed 1 course, and chemotherapy consisted of 4 courses. Surgery is carried out in 8 to 12 weeks after the end of chemotherapy. | ||
Interventions/Control_2 | |||
Interventions/Control_3 | |||
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Interventions/Control_5 | |||
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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) Histologically confirmed Rectum adenocarcinoma
2) Adequate following in the diagnostic imaging within 28 days before registration 1. Clinical stage T3, any N, or T4, any N 2. The edge of tumor is lower than Ra, Rb, P (Within 12cm from anal verge) 3. Unresectable rectal cancer by organ-sparing TME which was judged by high resolutoin MRI -CRM<=1mm -T4b -Lateral lymph node metastasis 3) Without liver, peritoneum and distant metastases 4)Age of 15-75 years 5)Without prior anti-tumor therapy (radiation therapy, chemotherapy and hormone therapy) 6)Aadequate function of important organs 1. WBC: >=3,000/mm3 and 12,000/mm3 2. Neutrophil: >=1,500/mm3 3. Platelet: >=100,000/mm3 4. Hemoglobin: >=9.0g/dL 5. T Bil: <=2.0mg/dL 6. AST, ALT: <100IU/L 7. Serum creatinine: <=1.2mg.DL 8. Creatinin clearance level >= 60mi/min 9. Urine protein<=1+ 10. INR<=1.5 7) ECG: without clinically problematic abnormalities within 28 days before registration 8) Eastern Cooperative Oncology Group performance status (PS) 0-1 9) With ability of oral intake 10) Written informed concent |
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Key exclusion criteria | 1) with gastrointestinal ulceration or bleeding
2) with sensory neuropathy 3) with severe diarrhea 4) had a previous serious drug allergies 5) had pleural effusion or ascites which need therapy 6) with brain metastasis or suspected the brain metastases 7) had surgery within 28 days before registration 8) had thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia 9) had serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension) 10) with active double cancer 11) had active infection disease (over 38.0 degree) 12) with significant abnormal electrocardiogram or cardiovascular disease (e.g. heart failure, myocardial infarction, angina pectoris) 13) receiving Flucytosine 14) pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant or men who want to get their partners pregnant 15) had hemoptysis (2.5 ml or more of fresh blood) 16) had gastrointestinal perforation within 6 months 17) were systemically-administered of steroids 18) with contraindications to TS-1, L-OHP, and Bevacizumab 19) with HBsAg-positive 20) Physician will determine that the patient is inappropriate participate in this trail for the safety. |
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Target sample size | 32 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hirosaki University Graduate School of Medicine | ||||||
Division name | Gstroenterological Surgery | ||||||
Zip code | 036-8562 | ||||||
Address | 5 Zaifu-chou, Hirosaki, Japan | ||||||
TEL | 0172395079 | ||||||
tmiura@hirosaki-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Hirosaki University Graduate School of Medicine | ||||||
Division name | Gstroenterological Surgery | ||||||
Zip code | 036-8562 | ||||||
Address | 5 Zaifu-chou, Hirosaki, Japan | ||||||
TEL | 0172-39-5079 | ||||||
Homepage URL | |||||||
tmiura@hirosaki-u.ac.jp |
Sponsor | |
Institute | Aomori Colorectal Cancer Study (ACCS) group |
Institute | |
Department |
Funding Source | |
Organization | none |
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 | Hirosaki University Certified Review Board |
Address | 1 Bunkyo-cho Hirosaki, Aomori |
Tel | 0172-39-5295 |
cksenta@hirosaki-u.ac.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Recruitment status | Open public recruiting | ||||||
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Management information | |||||||
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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=R000036106 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |