UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013267 |
|---|---|
| Receipt number | R000015473 |
| Scientific Title | A multi-institutional phase II study of preoperative chemotherapy with S-1, oxaliplatin and bevacizumab plus radiation for lower rectal cancer |
| Date of disclosure of the study information | 2014/03/10 |
| Last modified on | 2014/02/25 15:49:03 |
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Basic information
Public title
A multi-institutional phase II study of preoperative chemotherapy with S-1, oxaliplatin and bevacizumab plus radiation for lower rectal cancer
Acronym
A multi-institutional phase II study of preoperative chemotherapy with S-1, oxaliplatin and bevacizumab plus radiation for lower rectal cancer
Scientific Title
A multi-institutional phase II study of preoperative chemotherapy with S-1, oxaliplatin and bevacizumab plus radiation for lower rectal cancer
Scientific Title:Acronym
A multi-institutional phase II study of preoperative chemotherapy with S-1, oxaliplatin and bevacizumab plus radiation for lower rectal cancer
Region
| Japan |
Condition
Condition
lower rectal cancer
Classification by specialty
| Gastrointestinal surgery | Radiology | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of preoperative chemoradiotherapy with S-1, oxaliplatin and bevacizumab in patients with lower rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pathological Complete Response rate
Key secondary outcomes
Response rate(RR)
Relapse free survival (RFS)
Overall survival (OS)
Safety(rate of adverse events, rate of complications)
Rate of local recurrence
Completion rate of preoperative chemoradiotherapy
R0 resection rate
Down-staging rate
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
| Medicine | Maneuver |
Interventions/Control_1
S-1: Medication for 4 weeks of 5-day administration followed by 2-day washout at the dose of 80mg/m2
Oxaliplatin: Infusion for 2 hours at the dose of 50mg/m2 on day1, 8, 15, 22
Bevacizumab: Infusion for 90 minutes at the dose of 5mg/kg on day1, 15(administer second infusion over 60 minutes if first infusion is tolerated)
Radiation: 2Gy/day on day1-day5, day8-day12, day15-19, day22-26(total 40Gy)
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Histopathologically confirmed rectal cancer
2) By CT or ultrasound endoscope, the depth of invasion is resectable cases of N0-N3 and T2-T4
3) Main lesion of the tumor is located at lower rectal cancer (Rb, P)
4) Patients with measurable disease
5) Patients without peritoneal metastasis
6) Patients without distant metastases
7) Age of 20 to under 80 years
8) Performance status (ECOG basis) of 0-2
9)Sufficient organ function as below:
White blood cell count: 3,000/mm3 or more to 12,000/mm3
Neutrophil count:1,500/mm3 or more
Platelet count:100,000/mm3 or more
Hemoglobin amount:9.0g/dL or more
GPT and serum GOT:2.5 times or less than upper limit of normal
Total bilirubin:1.5mg/dL or less
Serum creatinine:1.2mg/dL or less
Creatinine clearance value:60mL/min or more(Estimated or measured)
10) No prior therapy for rectal cancer(chemotherapy, radiaotherapy and surgery)
11) Written informed consent
12) Ingestible cases
Key exclusion criteria
1) Cases of obvious abnormality in the chest X-ray or interstitial pneumonia, pulmonary fibrosis with clinical symptoms or history of these disease
2) Patients with body cavity effusion requiring treatment
3) Patients with active double cancer, or curatively treated double cancer that have been no-treatment and disease-free interval for 5 years or less (However, skin cancer or carcinoma in situ is excluded)
4) Patients with primary lesions having severe stenosis that endoscope does not pass (However, cases of colostomy can be registered)
5) Cases with confirmed peritoneal metastasis on the image
6) Cases with infection, paralysis of the intestinal tract, intestinal obstruction
7) Cases with diarrhea (watery diarrhea).
8) Cases with uncontrolled diabetes
9) Cases with uncontrolled high blood pressure
10) Cases with complications (heart failure (cardiac dysfunction), liver failure, renal failure, etc.) that are judged to lead to serious trouble
11) Patients with history of thrombosis, cerebral infarction, myocardial infarction, pulmonary infarction and hemoptysis
12) Cases with intraperitoneal inflammation
13) Cases with perceived failure or severe paresthesia with dysfunction
14) Cases with symptomatic brain metastases
15) Cases with congenital bleeding diathesis orthe coagulation system abnormalities
16) Cases with inappropriate study entry due to psychosis or psychiatric symptoms
17) Cases with pregnant women, the intention or possibility of pregnant women and nursing mothers
18) Patients who had experienced severe allergic drug reactions
19) Cases corresponding to the contraindication to each drug of this study
20) Patients with a history of hypersensitivity to each drug
21) Patients receiving systemic administration(intravenous or oral) of continued steroids
22) Patients receiving anticoagulant
23) Any other cases who are regarded as inadequate for study enrollment by physicians
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuo Shimada |
Organization
Tokushima University Hospital
Division name
Dept. of Digestive and Pediatric Surgery
Zip code
Address
3-18-15 Kuramoto-cho,Tokushoma,Japan
TEL
088-633-7139
ichigeka@clin.med.tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Higashijima |
Organization
Tokushima University Hospital
Division name
Dept. of Digestive and Pediatric Surgery
Zip code
Address
3-18-15 Kuramoto-cho,Tokushoma,Japan
TEL
088-633-7139
Homepage URL
j.jima@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Dept. of Digestive and Pediatric Surgery
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Hospital
Dept. of Digestive and Pediatric 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
Address
Tel
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
| 2014 | Year | 03 | Month | 10 | Day |
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
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 25 | Day |
Last modified on
| 2014 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015473
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| Registered date | File name |
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| Registered date | File name |
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