Unique ID issued by UMIN | UMIN000024357 |
---|---|
Receipt number | R000028039 |
Scientific Title | Phase II multicenter study of neoadjuvant chemotherapy with XELOX for locally advanced rectal cancer |
Date of disclosure of the study information | 2016/10/11 |
Last modified on | 2016/10/11 13:09:34 |
Phase II multicenter study of neoadjuvant chemotherapy with XELOX for locally advanced rectal cancer
KYNAC 02
Phase II multicenter study of neoadjuvant chemotherapy with XELOX for locally advanced rectal cancer
KYNAC 02
Japan |
Stage II or III rectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the safety and efficacy of neoadjuvant chemotherapy with XELOX for locally advanced rectal cancer
Efficacy
Confirmatory
Explanatory
Phase II
R0 resection rate
completion rate of the scheduled chemotherapy,Pathologic response rate,pathological complete response rate,downstage rate, OS, DFS, Local recurrence rate, Rate of sphincter-preservation, Completion rate of postoperative adjuvant chemotherapy, acute toxicity, postoperative complications,postoperative defecation
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Capecitabine: at a dose of 1000mg/m2 twice daily on days 1-14, 22-35,43-56,63-76
Oxaliplatin: at a dose of 130mg/m2 on days 1, 22,43,63
Surgical resection: 2-8 weeks after the completion of chemotherapy
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1. Histologically confirmed adenocarcinoma of the rectum
2.Patients with cT4 or cN2/3
3. Tumor with inferior edge located below peritoneal reflection
4. Without history of chemotherapy or radiotherapy for rectal cancer
5. Eastern Cooperative Oncology Group performance status of 0 or 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 <=1.5mg/dl
7. Written study-specific informed consent
1. With distant metastasis (M1)
2. Cancerous fluid
3. Active infectious disease
4. Concomitant malignancy (within 5 years) and double cancer
5. Uncontrolled diabetic
6. Peripheral neuropathy
7. Serious lung disease
8. Clinically significant cardiac disease
9. Pregnant women and nursing mothers, possibly pregnant women, and men attempting to conceive a child
10. Other conditions judged ineligible by physician
35
1st name | |
Middle name | |
Last name | Masafumi Nakamura,MD |
Graduate School of Medical Sciences, Kyushu University
Surgery and Oncology
3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan
092-642-5437
mnaka@surg1.med.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Tatsuya Manabe,MD |
Graduate School of Medical Sciences, Kyushu University
Surgery and Oncology
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
092-642-5440
manabe@surg1.med.kyushu-u.ac.jp
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
None
Self funding
Surgical Oncology Group of Kyushu and Yamaguchi (SOGKY)
NO
2016 | Year | 10 | Month | 11 | Day |
Unpublished
Preinitiation
2016 | Year | 01 | Month | 25 | Day |
2016 | Year | 10 | Month | 31 | Day |
2016 | Year | 10 | Month | 11 | Day |
2016 | Year | 10 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028039
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |