UMIN-CTR Clinical Trial

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
Email	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
Email	takaota@gifu-u.ac.jp

Sponsor
Institute	PerSeUS:Perpetual Study estimated-by United Sections in Gifu
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
Address
Tel
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013868