UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019606 |
|---|---|
| Receipt number | R000022660 |
| Scientific Title | Phase II study of S-1 and L-OHP neoadjuvant chemotherapy with total mesorectal excision and lateral lymph node dissection for resectable rectal cancer (ACCS-01) |
| Date of disclosure of the study information | 2015/11/10 |
| Last modified on | 2018/11/04 09:13:07 |
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Basic information
Public title
Phase II study of S-1 and L-OHP neoadjuvant chemotherapy with total mesorectal excision and lateral lymph node dissection for resectable rectal cancer (ACCS-01)
Acronym
NAC(SOX+LLND) for rectal cancer (ACCS-01)
Scientific Title
Phase II study of S-1 and L-OHP neoadjuvant chemotherapy with total mesorectal excision and lateral lymph node dissection for resectable rectal cancer (ACCS-01)
Scientific Title:Acronym
NAC(SOX+LLND) for rectal cancer (ACCS-01)
Region
| Japan |
Condition
Condition
locally advanced rectal cancer
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to explore the efficacy and safety of S-1 and L-OHP neoadjuvant chemotherapy with total mesorectal excision and lateral lymph node dissection for resectable rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
cumulative recal recurrence rate
Key secondary outcomes
Relapse free survival, Overall survival, Treatment completion rate, Down-staging rate, Safety, sphincter-preservation rate, time from definite diagnosis to initiation of therapy
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 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 adose of 130mg/m2/day. 21 days are assumed 1 course, and neoadjuvant chemotherapy consisted of 3 courses. Surgery is carried out in 3 to 8 weeks after the end of chemotherapy.
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 Rectum adenocarcinoma
2) Adequate following in the diagnostic imaging within 28 days before registration
-Clinical stage T3, any N, or T4, any N
-Main lesion of the tumor is located at the Ra or Rb
-The edge of tumor is lower than the peritoneal reflection
-Not diffuse infiltrating carcinoma.
3) Without liver, peritoneum and distant metastases
4)Age of 20-80 years
Possigle to R0 resection
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. AST, ALT: <100IU/L
6. T Bil: <=2.0mg/dL
7. Serum creatinine: <=1.2mg.DL
8. creatinin clearance level >= 60mi/min
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
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) were systemically-administered of steroids
16) with contraindications to TS-1 and L-OHP
17) with HBsAg-positive
18) Physician will determine that the patient is inappropriate participate in this trail for the safety.
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Morohashi |
Organization
ACCS
Division name
Hirosaki University Hospital
Zip code
Address
Hontyo53, Hiroski City, Aomori Pref.
TEL
0172-33-5111
hm2002@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Morohashi |
Organization
ACCS
Division name
Hirosaki University Hospital
Zip code
Address
Hontyo53, Hiroski City, Aomori Pref.
TEL
0172-33-5111
Homepage URL
hm2002@hirosaki-u.ac.jp
Sponsor or person
Institute
Gastroenterological surgery, Hirosaki University
Institute
Department
Personal name
Funding Source
Organization
non
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
| 2015 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | 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
| 2015 | Year | 11 | Month | 02 | Day |
Last modified on
| 2018 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022660
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