UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011861 |
|---|---|
| Receipt number | R000013868 |
| Scientific Title | A phase II study of preoperative concurrent chemoradiotherapy with TS-1/ Oxaliplatin in patients with locally advanced rectal cancer(PerSeUS-RC01) |
| Date of disclosure of the study information | 2013/09/25 |
| Last modified on | 2020/06/11 13:48:10 |
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Basic information
Public title
A phase II study of preoperative concurrent chemoradiotherapy with TS-1/ Oxaliplatin in patients with locally advanced rectal cancer(PerSeUS-RC01)
Acronym
A phase II study of neoadjuvant SOX + RT for locally advanced rectal cancer(PerSeUS-RC01)
Scientific Title
A phase II study of preoperative concurrent chemoradiotherapy with TS-1/ Oxaliplatin in patients with locally advanced rectal cancer(PerSeUS-RC01)
Scientific Title:Acronym
A phase II study of neoadjuvant SOX + RT for locally advanced rectal cancer(PerSeUS-RC01)
Region
| Japan |
Condition
Condition
locally advanced rectal cancer
Classification by specialty
| Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of preoperative concurrent chemoradiotherapy with TS-1 / Oxaliplatin in patients with locally advanced rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological effect
Key secondary outcomes
Pathological complete response rate
R0 resection rate
Disease free survival
Overall survival
Local recurrence rate
Distant recurrence rate
Safety
Relative Dose Intensity
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
Chemoradiaotherapy
TS-1: TS-1 is administered orally twice daily at a dose of 80-120 mg/day on Days 1-5, 8-12, 22-26, 29-33.
Oxaliplatin: Oxaliplatin is administered intravenously at a dose of 50 mg/m2 on Days 1, 8, 22, 29.
Radiation: 1.8 Gy/day 25 times (total 45 Gy)
Chemotherapy
Chemotherapy with TS-1 and oxaliplatin will be performed after chemoradiotherapy.
TS-1: TS-1 is administered orally twice daily at a dose of 80-120 mg/day on days 1-14 every 21 days.
Oxaliplatin: Oxaliplatin is administered intravenously at a dose of 130 mg/m2 on Day 1 every 21 days.
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) Main lesion of the tumor is located at the Ra or Rb
2) Histologically confirmed rectum adenocarcinoma (tub1/tub2)
3) Clinical stage T3 or T4 (any N)
4) Possible to R0 resection
5) Without metastases
6) Age of 20 to 80 years
7) An Eastern Cooperative Oncology Group performance status of 0 or 1
8) No prior therapy (radiotherapy, chemotherapy and endocrine therapy)
9) Sufficient organ function as below :
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. Serum total bilirubin: <=2.0mg/dL
7. Serum creatinine: <=1.2mg.DL
8. Creatinine clearance: >= 60mL/min
10) Adequate oral intakes
11) Written informed concent
Key exclusion criteria
1) History of Severe drug allergy
2) Active infections (over 38.0 degree)
3) Severe concurrent disease (interstitial pneumonitis or pulmonary fibrosis, poorly controlled diabetes, renal failure or hepatic failure)
4) Severe aberration of electrocardiogram, schemic heart disease, arrhythmia, cardiac infarction or heart failure.
5) Sensory neuropathy
6) Watery diarrhea
7) Massive pleural effusion or ascites
8) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less)
9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy
10) Current use of flucytosine
11) Positive hepatitis-B antigen
12) 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 | Kazuhiro Yoshida |
Organization
Gifu University graduate school of medicine
Division name
Department of surgical oncology
Zip code
Address
1-1 Yanagido, Gifu city
TEL
058-230-6000
kyoshida@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Takahashi |
Organization
Gifu University graduate school of medicine
Division name
Department of surgical oncology
Zip code
Address
1-1 Yanagido, Gifu city
TEL
058-230-6000
Homepage URL
takaota@gifu-u.ac.jp
Sponsor or person
Institute
PerSeUS:Perpetual Study estimated-by United Sections in Gifu
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
| 2013 | Year | 09 | Month | 25 | 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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 26 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 25 | Day |
Last modified on
| 2020 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013868
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