Unique ID issued by UMIN | UMIN000032871 |
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Receipt number | R000037365 |
Scientific Title | 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 | 2024/02/14 10:14:32 |
Japanese phase II trial of NEoadjuvant chemotherapy Using TRiplet for borderline resectable Advanced rectaL cancer
NEUTRAL trial
Japanese phase II trial of NEoadjuvant chemotherapy Using TRiplet for borderline resectable Advanced rectaL cancer
NEUTRAL trial
Japan |
borderline resectable advanced rectal cancer
Gastrointestinal surgery |
Malignancy
NO
To evaluate the safety and efficacy of neoadjuvant chemotherapy with FOLFOXIRI for borderline resectable advanced rectal cancer
Safety,Efficacy
Confirmatory
Explanatory
Phase II
R0 resection rate
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Radical surgery after 6cources of neoadjuvant FOLFOXIRI
20 | years-old | <= |
74 | years-old | >= |
Male and Female
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
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.
30
1st name | Masafumi |
Middle name | |
Last name | Nakamura |
Graduate School of Medical Sciences, Kyushu University
Surgery and Oncology
812-8582
3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan
092-642-5440
nakamura.masafumi.861@m.kyushu-u.ac.jp
1st name | Kinuko |
Middle name | |
Last name | Nagayoshi |
Graduate School of Medical Sciences, Kyushu University
Surgery and Oncology
812-8582
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
092-642-5440
nagayoshi.kinuko.232@m.kyushu-u.ac.jp
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu Universit
None
Self funding
Surgical Oncology Group of Kyushu and Yamaguchi (SOGKY)
KYUSHU UNIVERSITY Center for Clinical and Translational Research(CCTR)
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
092-642-5774
ijkseimei@jimu.kyushu-u.ac.jp
NO
2018 | Year | 06 | Month | 11 | Day |
Unpublished
5
Terminated
2018 | Year | 05 | Month | 14 | Day |
2018 | Year | 06 | Month | 13 | Day |
2018 | Year | 10 | Month | 22 | Day |
2023 | Year | 03 | Month | 23 | Day |
2018 | Year | 06 | Month | 05 | Day |
2024 | Year | 02 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037365
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