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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032871
Receipt No. R000037365
Official scientific title of the study Japanese phase II trial of NEoadjuvant chemotherapy Using TRiplet for borderline resectable Advanced rectaL cancer
Date of disclosure of the study information 2018/06/11
Last modified on 2018/06/19

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Basic information
Official scientific title of the study Japanese phase II trial of NEoadjuvant chemotherapy Using TRiplet for borderline resectable Advanced rectaL cancer
Title of the study (Brief title) NEUTRAL trial
Region
Japan

Condition
Condition borderline resectable advanced rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of neoadjuvant chemotherapy with FOLFOXIRI for borderline resectable advanced rectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes R0 resection rate
Key secondary outcomes completion rate of the scheduled chemotherapy, pathological complete response rate, rate of tumor shrinkage, pathological response, clinical response rate, downstage rate, overall survival, recurrence-free survival, rate of sphincter-preserving surgery, administration rate of adjuvant chemotherapy, adverse event, postoperative complication

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Radical surgery after 6cources of neoadjuvant FOLFOXIRI
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1. Lower rectal cancer patients with cT4a with circumferential resection margin<1mm or cT4b or cN2/3
2. Histologically proven adenocarcinoma of the rectum
3.Tumor with inferior edge located below peritoneal reflection
4.Without history of chemotherapy or radiotherapy for rectal cancer
5. Performance status (PS) 0-1
6.Adequate organ function
i) WBC >=3,000/mm3
ii) Neutrophil count >=1,500/mm3
iii) Platelet count >=100,000/mm3
iv) Serum bilirubin <=2.0mg/dl
v) AST <=100IU/l
vi) ALT <=100IU/l
vii) Serum creatinine <=1.3mg/dl
7. Indication for laparoscopic surgery
8. Written informed consent
Key exclusion criteria 1. With distant metastasis (M1)
2. Transfusion of blood derivative within 14 days
3. Existence of cancer cells in ascites
4. With active infection
5. Synchronous or metachronous malignant tumor
6. uncontrolled diabetes mellitus
7. History of severe drug hypersensitivity
8. History of sensational abnormality
9. With interstitial lung disease or pulmonary fibrosis
10. Severe heart failure
11. Pregnant
12. Patients who do not give written informed consent.
Target sample size 30

Research contact person
Name of lead principal investigator Masafumi Nakamura, M.D., Ph.D.
Organization Graduate School of Medical Sciences, Kyushu University
Division name Surgery and Oncology
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan
TEL 092-642-5440
Email mnaka@surg1.med.kyushu-u.ac.jp

Public contact
Name of contact person Kinuko Nagayoshi, M.D., Ph.D.
Organization Graduate School of Medical Sciences, Kyushu University
Division name Surgery and Oncology
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5440
Homepage URL
Email k121@surg1.med.kyushu-u.ac.jp

Sponsor
Institute Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu Universit
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Surgical Oncology Group of Kyushu and Yamaguchi (SOGKY)
Name of secondary funder(s)

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
2018 Year 06 Month 11 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 05 Month 14 Day
Anticipated trial start date
2018 Year 06 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 05 Day
Last modified on
2018 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037365

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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