Unique ID issued by UMIN | UMIN000008316 |
---|---|
Receipt number | R000009791 |
Scientific Title | Phase II study of XELOX as perioperative chemotherapy for locally advanced rectal cancer |
Date of disclosure of the study information | 2012/07/03 |
Last modified on | 2012/07/02 10:06:21 |
Phase II study of XELOX as perioperative chemotherapy for locally advanced rectal cancer
CORONA I
Phase II study of XELOX as perioperative chemotherapy for locally advanced rectal cancer
CORONA I
Japan |
Locally advanced rectal cancer
Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy and safety of perioperative chemotherapy with XELOX for locally advanced rectal cancer
Safety,Efficacy
Confirmatory
Explanatory
Phase II
3-y relapse-free survival rate
Overall survival rate, Local recurrence-free survival rate, Pathological complete response rate, Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Periooerative chemotherapy with XELOX for locally advanced rectal cancer
20 | years-old | <= |
80 | years-old | >= |
Male and Female
(1)Writen informed consent
(2)Histologically proven adenocarcinoma of the rectum
(3)Clinical confirmed locally advanced rectal cancer
(4)Without distant metastases (M0)
(5)Age: 20-80 years
(6)Performance status (PS) 0-1
(7)Alife expectancy greater than 12 weeks
(8)Without prior radiotherapy for the pelvis
(9)Adequate organ function
(1)Multiple malignacies to be treated
(2)Uncontrollable peptic ulcer disease
(3)Serious complications
(4)Previous history of severe drug-induced allergy
(5)Severe neuropathy
(6)With interstitial lung disease or pulmonary fibrosis
(7)Pregnant
(8)Prior chemotherapy with oxaliplatin or capecitabin
(9)Disqualified by attending doctor
60
1st name | |
Middle name | |
Last name | Masato Nagino |
Nagoya University Graduate School of Medicine
Division of Surgical Oncology
65 Tsurumai-cho Showa-ku Nagoya,466-8550,Japan
052-744-2222
1st name | |
Middle name | |
Last name | Keisuke Uehara |
Nagoya University Graduate School of Medicine
Division of Surgical Oncology
65 Tsurumai-cho Showa-ku Nagoya,466-8550,Japan
052-744-2222
kuehara@med.nagoya-u.ac.jp
Nagoya Surgical Oncology Group
None
Self funding
NO
2012 | Year | 07 | Month | 03 | Day |
Unpublished
Enrolling by invitation
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 07 | Month | 02 | Day |
2012 | Year | 07 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009791
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |