UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008203 |
|---|---|
| Receipt number | R000009670 |
| Scientific Title | Phase2 study of perioperative XELOX in patients with locally-advanced lower rectal cancer |
| Date of disclosure of the study information | 2012/06/19 |
| Last modified on | 2021/05/25 15:55:46 |
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Basic information
Public title
Phase2 study of perioperative XELOX in patients with locally-advanced lower rectal cancer
Acronym
Phase2 study of perioperative XELOX in patients with locally-advanced lower rectal cancer
Scientific Title
Phase2 study of perioperative XELOX in patients with locally-advanced lower rectal cancer
Scientific Title:Acronym
Phase2 study of perioperative XELOX in patients with locally-advanced lower rectal cancer
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of perioperative chemotherapy using capecitabine and oxaliplatin in patients with locally advanced rectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
2 year disease free survival
Key secondary outcomes
Operation rate, Safety, Down staging rate, Pathological complete response rate, Pathological effect, 2 year local recarence rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Perioperative chemotherapy with XELOX, preoperative 4 cycles followed by postoperative 4 cycles
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 25 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Written informed consent
2) >=20years-old <=75 years-old
3) ECOG performance status 0-1
4) Recral cancer(Ra, Rb)
5) Clinical stage T3 or T4 and/or lymph node positive.
6) No prior chemotherapy or radiotherapy
7) Adequate organ function
Key exclusion criteria
1) Need to drain malignant coelomic fluid.
2) With distant metastases
3) Multiple primary cancer within 5years
4) Symptomatic or asymptomatic but treated heart disease
5) History of the serious hypersensitivity for Fluorouracil, platinum compound and levofolinate calcium
6) History of adverse events related to DPD loss
7) Uncontrolled Diarrhea
8) Peripheral neuropathy(Grade1<=)
9) Uncontrolled infection
10) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers
11) No intention to practice birth control
12) Previously treated with oxaliplatin
13) Other conditions not suitable for this study
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Hasegawa |
Organization
Osaka rosai hospital
Division name
Surgery
Zip code
591-8025
Address
1179-30 Nagasone Kita Ward Sakai City Osaka
TEL
072-252-3561
j-hasegawa@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | Tsunekazu |
| Middle name | |
| Last name | Mizushima |
Organization
Osaka University Graduate School of Medicine
Division name
Gastroenterological Surgery
Zip code
565-0871
Address
2-15 Yamadaoka Suita-city Osaka,Japan
TEL
06-6879-3251
Homepage URL
tmizushima@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital
Address
2-15 Yamadaoka, Suita, Osaka 565-0871,Japan
Tel
06-6879-5685
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 19 | Day |
Last modified on
| 2021 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009670
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/07/06 | 局所進行直腸癌に対する周術期XELOX療法に関する有効性の検討(PhaseⅡ Study).zip |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
