UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016518 |
|---|---|
| Receipt number | R000019182 |
| Scientific Title | A phase II trial of preoperative chemotherapy with capecitabine plus short-course radiotherapy for resectable T3 rectal cancer |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2015/02/12 17:06:38 |
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Basic information
Public title
A phase II trial of preoperative chemotherapy with capecitabine plus short-course radiotherapy for resectable T3 rectal cancer
Acronym
A phase II trial of preoperative chemotherapy with capecitabine plus short-course radiotherapy for resectable T3 rectal cancer
Scientific Title
A phase II trial of preoperative chemotherapy with capecitabine plus short-course radiotherapy for resectable T3 rectal cancer
Scientific Title:Acronym
A phase II trial of preoperative chemotherapy with capecitabine plus short-course radiotherapy for resectable T3 rectal cancer
Region
| Japan |
Condition
Condition
resectable T3 rectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of preoperative short course radiotherapy(25Gy/10fraction/5days) with capecitabine for T3 rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tumor regression score Grade 2+3
Key secondary outcomes
Safety (rate of adverse events, rate of complication)
Completion rate of preoperative chemoradiotherapy
R0 resection rate
Down-staging rate
Down-sizing rate
LFS; local recurrence free survival
RFS; Recurrence free survival
OS; Overall survival
bowel, urinary and sexual 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
Capecitabine: Treatment dose was decided by body mass index and prescribed day 1 to day 10 of continuous 10 days.
Radiotherapy: A total dose of 25 Gy of radiotherapy was administered in 10 fractions of 2.5 Gy each for five days (25 Gy/10 fractions/5 days)
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 Rectum adenocarcinoma
2. Preoperative findings
*The clinical stage is T3 and N0-2
*Main lesion of the tumor is located at the Rb
*No extra mesorectal lymph node swelling (longest diameter is less than 8 mm)
*Not type 4(Diffuse Infiltrative Type)
3. No evidence of peritoneal metastasis, liver metastasis and distant metastasis
4. Age:20-80years old
5. Without prior anti-tumor therapy
6. Adequate organ function
7. Normal ECG
8. Performance status 0-1
9. Oral intake possible
10.Written IC
Key exclusion criteria
1.Previous history of severe drug-induced allergy
2.Multiple malignancies to be treated or synchronous colorectal cancer
3. Active infections
4. Serious complications
5.Previous history of Interstitial Pneumonitis
6.Pleural effusion or ascites requiring treatment.
7. Active digestive tract bleeding
8. Severe watery diarrhea
9. Pregnant or nursing
10.Systemic administration of corticosteroids
11. Patients of hepatitis B virus suface antigen positivity
12.Contraindication of S-1or CPT-11
13. Patients judged inappropriate for this study by the physicians
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Yanagi |
Organization
Meiwa Hospital
Division name
Surgery
Zip code
Address
4-31 Agenaruo Nishinomiya Hyogo
TEL
0798-47-1767
yanagih@meiwa-hospital.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohito Beppu |
Organization
Meiwa Hospital
Division name
Surgery
Zip code
Address
4-31 Agenaruo Nishinomiya Hyogo
TEL
0798-47-1767
Homepage URL
beppu-n@hyo-med.ac.jp
Sponsor or person
Institute
Meiwa Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | 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
| 2015 | Year | 02 | Month | 12 | Day |
Last modified on
| 2015 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019182
