UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007087 |
|---|---|
| Receipt number | R000008346 |
| Scientific Title | The Efficacy Study of Neoadjuvant Xelox in Patients with Locally Advanced Lower Rectal Cancer |
| Date of disclosure of the study information | 2012/01/31 |
| Last modified on | 2016/10/13 09:51:07 |
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Basic information
Public title
The Efficacy Study of Neoadjuvant Xelox in Patients with Locally Advanced Lower Rectal Cancer
Acronym
Neoadjuvant Xelox for locally advanced rectal cancer
Scientific Title
The Efficacy Study of Neoadjuvant Xelox in Patients with Locally Advanced Lower Rectal Cancer
Scientific Title:Acronym
Neoadjuvant Xelox for locally advanced rectal cancer
Region
| Japan |
Condition
Condition
Lower rectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of neoadjuvant chemotherapy using capecitabine and oxaliplatin in patients with locally advanced lower rectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
R0 resection rate
Key secondary outcomes
OS, DFS, Local recurrence rate, Rate of sphincter-preservation, Pathologic response rate, Completion rate of postoperative adjuvant chemotherapy, acute toxicity, postoperative complications
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
Capecitabine: at a dose of 1000mg/m2 twice daily on days 1-14, 22-35, 43-56
Oxaliplatin: at a dose of 130mg/m2 on days 1, 22 and 43
Surgical resection: 2-6 weeks after the completion of chemotherapy
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed adenocarcinoma of the rectum
2. Clinical stage II or III, determined by CT, MRI or EUS
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
Key exclusion criteria
1. Lateral node involvement
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
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Nakamura,MD |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Surgery and Oncology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5437
mnaka@surg1.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Manabe,MD |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Surgery and Oncology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5440
Homepage URL
manabe@surg1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
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
Surgical Oncology Group of Kyushu and Yamaguchi (SOGKY)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 01 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 17 | Day |
Last modified on
| 2016 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008346
