UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015320 |
|---|---|
| Receipt number | R000017434 |
| Scientific Title | Phase II study of neoadjuvant chemotherapy with SOX + bevacizumab in patients with locally advanced rectal cancer |
| Date of disclosure of the study information | 2014/10/02 |
| Last modified on | 2014/10/02 14:25:48 |
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Basic information
Public title
Phase II study of neoadjuvant chemotherapy with SOX + bevacizumab in patients with locally advanced rectal cancer
Acronym
Phase II study of neoadjuvant chemotherapy with SOX + bevacizumab in patients with locally advanced rectal cancer
Scientific Title
Phase II study of neoadjuvant chemotherapy with SOX + bevacizumab in patients with locally advanced rectal cancer
Scientific Title:Acronym
Phase II study of neoadjuvant chemotherapy with SOX + bevacizumab in patients with locally advanced rectal cancer
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of neoadjuvant chemotherapy with SOX + bevacizumab in patients with locally advanced rectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
R0 resection 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
| Medicine |
Interventions/Control_1
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)
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) Histologically confirmed adenocarcinoma of the rectum
2) Patients meet all the following criteria by radiological or physical examination before enrollment
i) Main part of the tumor is located in Ra, Rb, P (Rs should be excluded)
ii) Distal border of the tumor is located between peritoneal reflection and anal verge
3) Patients meet either of the following criteria by CT, MRI, or endorectal ultrasound
i) Tumors invade mesorectum beyond rectal muscularis propria
*Tumors which directly invade other organs should be excluded
ii) Lymph node metastases are in the mesorectum (>10 mm in short axis)
* Lymphadenopathy (>5 mm in short axis) in the lateral position should be excluded
4) ECOG Performance Status of 0-1
5) Age of 20 to 80 years
6) Adequate major organ functions within 2 weeks before enrollment, as defined below:
WBC count => 3,000/mm3, <= 12,000/mm3
Neutrophil count => 1,500/mm3
Platelet count => 100,000/mm3
Hemoglobin => 9.0 g/dL
Total bilirubin <= 1.5 x ULN
AST <= 2.5 x ULN
ALT <= 2.5 x ULN
ALP <= 5.0 x ULN
Creatinine <= 1.5 x ULN
CCr => 60 ml/min
urinary protein <= 1+
INR <= 1.5
7) Written informed consent
Key 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.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Furukawa |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterologic and General Surgery
Zip code
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2503
f-hiro@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Yamada |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterologic and General Surgery
Zip code
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2503
Homepage URL
ridai@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
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
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 | 10 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | 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 | 10 | Month | 02 | Day |
Last modified on
| 2014 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017434
