Unique ID issued by UMIN | UMIN000008429 |
---|---|
Receipt number | R000009917 |
Scientific Title | Phase II study of XELOX as adjuvant chemotherapy for locally advanced rectal cancer |
Date of disclosure of the study information | 2012/07/13 |
Last modified on | 2015/01/14 10:04:53 |
Phase II study of XELOX as adjuvant chemotherapy for locally advanced rectal cancer
CORONAII
Phase II study of XELOX as adjuvant chemotherapy for locally advanced rectal cancer
CORONAII
Japan |
Locally advanced rectal cancer
Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy and safety of adjuvant chemotherapy with XELOX for locally advanced rectal cancer
Safety,Efficacy
Confirmatory
Explanatory
Phase II
3-y relapse-free survival rate
Local recurrence-free survival rate,
Relative dose intensity, Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Adjuvant 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
40
1st name | |
Middle name | |
Last name | Yasuhiro Kodera |
Nagoya University Graduate School of Medicine
Gastroenterological Surgery
65 Tsurumai-cho Showa-ku Nagoya,466-8550,Japan
052-744-2250
ykodera@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Goro Nakayama |
Nagoya University Graduate School of Medicine
Gastroenterological Surgery
65 Tsurumai-cho Showa-ku Nagoya,466-8550,Japan
052-744-2253
goro@med.nagoya-u.ac.jp
Chubu Clinical Oncology Group(CCOG)
none
Self funding
NO
2012 | Year | 07 | Month | 13 | Day |
Unpublished
Enrolling by invitation
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 07 | Month | 13 | Day |
2015 | Year | 01 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009917
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |