UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037000 |
|---|---|
| Receipt number | R000041894 |
| Scientific Title | Limited Surgery for T1 or T2 lower rectal Cancer with neoadjuvant chemoradiotherapy |
| Date of disclosure of the study information | 2019/06/10 |
| Last modified on | 2019/06/07 20:13:29 |
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Basic information
Public title
Limited Surgery for T1 or T2 lower rectal Cancer with neoadjuvant chemoradiotherapy
Acronym
Limited Surgery for T1 or T2 lower rectal Cancer with neoadjuvant chemoradiotherapy
Scientific Title
Limited Surgery for T1 or T2 lower rectal Cancer with neoadjuvant chemoradiotherapy
Scientific Title:Acronym
Limited Surgery for T1 or T2 lower rectal Cancer with neoadjuvant chemoradiotherapy
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 investigate safety and efficacy of combination therapy of limited Surgery with neoadjuvant chemoradiotherapy for T1 or T2 lower rectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological complete response rate
Key secondary outcomes
Relapse-free survival
Disease-free survival
Overall survival
Local relapse-free survival
Adverse events
Anal sphincter preservation
Anal function
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
| Medicine |
Interventions/Control_1
Xeloda was given orally after breakfast and dinner on Days 1 to 5, 8 to 12, 22 to 26, and 29 to 33.
Radiotherapy was administered in fractions of 1.8 Gy/d, given 5 days per week for 5 weeks. The total dose of radiation was 45 Gy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Main part of the tumor is located in P-Rb.
2) Previously untreated lower rectal cancer with preoperative diagnosis of T1/2 and N0 and M0.
3) Tumor diameter=< 30mm.
4) Well differentiated adenocarcinoma or Moderately differentiated adenocarcinoma.
5) No prior therapy expect the operation.
6) No severe complications
7) Age >= 20 years
8) Performance status (ECOG) of 0-1
9) Capability of oral intake
10) Patients who have satisfied the following the clinical test values within two weeks before the registration.
i. WBC: 3,500-12,000 /mm3
ii. Neutrophile >= 1,500/mm3
iii. Platelet > = 100,000/mm3
iv. Hemoglobin > = 9.0g/dL
v. Total bilirubin =< 2.0 mg/dL
vi. AST =< 100IU/L
vii. ALT =< 100IU/L
viii. Ccr >= 30 ml/min
11) Written informed consent.
Key exclusion criteria
1) Active synchronous or metachronous malignancy carcinoma in situ.
2) Non-treated radiotherapy
3) Medical history of severe anaphylaxis or allergia to any drug.
4) Severe diarrhea.
5) Undergoing treatment with Tegafur, Gimeracil, Oteracil Potassium.
6) Undergoing treatment with Warfarin Potassium, Phenytoin, Trifluridine, Tipiracil Hydrochloride.
7) Severe complication.
8) Pregnant or lactating woman at any time during study. Men of the fertility hope.
9) Severe mental disorder.
10) Patients judged inappropriate for the study by their physicians.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hasegawa |
| Middle name | |
| Last name | Junichi |
Organization
Osaka Rosai Hospital
Division name
Department of Surgery
Zip code
591-8025
Address
1179-3 Nagasonecho, Kita-ku, Sakai 591-8025, Japan
TEL
072-252-3561
j-hasegawa@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | Sueda |
| Middle name | |
| Last name | Toshinori |
Organization
Osaka Rosai Hospital
Division name
Department of Surgery
Zip code
591-8025
Address
1179-3 Nagasonecho, Kita-ku, Sakai 591-8025, Japan
TEL
072-252-3561
Homepage URL
tsueda@osakah.johas.go.jp
Sponsor or person
Institute
Osaka Rosai 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
Osaka Rosai Hospital
Address
1179-3 Nagasonecho, Kita-ku, Sakai 591-8025, Japan
Tel
072-252-3561
tsueda@osakah.johas.go.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
| 2019 | Year | 06 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 07 | Day |
Last modified on
| 2019 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041894
