Unique ID issued by UMIN | UMIN000018624 |
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Receipt number | R000021553 |
Scientific Title | A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer. |
Date of disclosure of the study information | 2015/08/10 |
Last modified on | 2018/02/15 11:21:44 |
A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.
A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.
A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.
A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.
Japan |
Rectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
Safety, Efficacy
Safety,Efficacy
Confirmatory
Phase II
RFS:3 years relapse free survival
Response rate, Proportion of patients with R0 resection, Pathological response, 3 years progression free survival, 3 years overall survival, Incidence of adverse events, Proportion of operative complication, Proportion of anus-preservation without stoma, Evaluation of anal function, Evaluation of bladder function
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Medicine | Maneuver |
preoperative FOLFOXIRI+surgery
preoperative chemoradiotherapy+surgery
20 | years-old | <= |
74 | years-old | >= |
Male and Female
1. Pathologically proven adenocarcinoma.
2. Primary tumor located at Rectosigmoid, Upper rectum, Lower rectum, and Anal canal.The lower border of the tumor located between the peritoneal reflection and the anal verge.
3. cT3and cT4a tumor on contrast-enhanced CT or MRI
4. Lateral lymph nodes without 7mm and more in short axis diameter on contrast-enhanced CT or MRI data of 5mm-thickness slices (cN0-cN2) .
5. No distant metastasis on contrast-enhanced CT or MRI (cM0)
6. Aged 20 to 74 years old
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
8. Adequate organ function as evidenced by the following laboratory studies within 14 days prior to enrollment
1) Neutrophil count >= 1,500 /mm3
2) Platelet count >= 100,000 /mm3
3) Hemoglobin >= 9.0 g/dL
4) T.Bil =< 2.0 mg/dL
5) AST =< 100 IU/L, ALT =< 100 IU/L
6) Cr =< 1.5 mg/dL
9. Written informed consent
1. Currently treated with systemic steroids or immunosuppressive agent
2. Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma
3. Infectious disease to be treated
4. Positive for HBs antigen
5. Uncontrollable hypertension, Uncontrollable diabetes mellitus, Uncontrollable arrhythmia, and severe clinical problem
6. Grade 1 or more peripheral neuropathy
7. Women during pregnancy, possible pregnancy or breast-feeding
8. Severe mental disease
9. Attending physician determines that the case was inappropriate as the subject of this study
34
1st name | |
Middle name | |
Last name | Kazuhisa Uchiyama |
Osaka Medical College Hospital
Department of general and gastroenterological surgery
2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
072-683-1221
uchi@poh.osaka-med.ac.jp
1st name | |
Middle name | |
Last name | Keitarou Tanaka |
Osaka Medical College Hospital
Department of general and gastroenterological surgery
2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
072-683-1221
sur036@poh.osaka-med.ac.jp
Osaka Medical College Hospital
Osaka Medical College Hospital
Self funding
NO
大阪医科大学附属病院
2015 | Year | 08 | Month | 10 | Day |
Unpublished
Completed
2015 | Year | 07 | Month | 06 | Day |
2015 | Year | 08 | Month | 20 | Day |
2015 | Year | 08 | Month | 10 | Day |
2018 | Year | 02 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021553
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