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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000962
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Dept. Surgery
Kyoto University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001157

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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