UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000962 |
|---|---|
| Receipt number | R000001157 |
| Scientific Title | Phase II study of neoadjuvant chemotherapy TS-1/CPT-11 for advanced lower rectal cancers |
| Date of disclosure of the study information | 2008/01/01 |
| Last modified on | 2007/12/30 16:51:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II study of neoadjuvant chemotherapy TS-1/CPT-11 for advanced lower rectal cancers
Acronym
Phase II study of neoadjuvant chemotherapy TS-1/CPT-11 for advanced lower rectal cancers
Scientific Title
Phase II study of neoadjuvant chemotherapy TS-1/CPT-11 for advanced lower rectal cancers
Scientific Title:Acronym
Phase II study of neoadjuvant chemotherapy TS-1/CPT-11 for advanced lower rectal cancers
Region
| Japan |
Condition
Condition
Rectal cancers
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of neoadjuvant chemotherapy TS-1/CPT-11 for advanced lowere rectal cancers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-year disease-free survival rates
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Chemotherapy
Surgery
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) Advanced lower rectal cancers with preoperative diagnosis as below:
(a) T3 or resectable T4 of 5cm in minimal diameter
(b) Massive lymph node metastases in the mesorectum
(c) Metastatic lymph nodes located outside the pelvic plexus, along the internal iliac and common iliac vessels and in the obturator cavity
2) Performance status (ECOG): 0-1
3) Vital organ functions, including hematopoietic, cardiac, respiratory and renal functions, are preserved.
4) No evidence of distant metastases
5) No prior treatment histories of radiotherapy and/or chemotherapy for rectal cancers.
Key exclusion criteria
Excluded are cases with conditions as below:
1) Multiple malignancies to be treated.
2) Previous history of severe drug-induced allergy.
3) Active infectious diseases.
4) Coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure.
5) Peritoneal or pleural fluid retention to be drainaged.
6) Symptomatic brain metastases.
7) Active digestive tract bleeding.
8) Severe watery diarrhea.
9) Pregnant.
10) Previous treatment history of radiotherapy.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Nagayama |
Organization
Kyoto University Hospital
Division name
Surgery
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto City
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Hospital
Division name
Surgery
Zip code
Address
TEL
075-751-3227
Homepage URL
Sponsor or person
Institute
Dept. Surgery
Kyoto University Hospital
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
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
| 2008 | Year | 01 | Month | 01 | 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
Date of protocol fixation
| 2007 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 12 | Month | 30 | Day |
Last modified on
| 2007 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001157
