UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012559 |
|---|---|
| Receipt number | R000014663 |
| Scientific Title | The pilot study on surgical safety after neoadjuvant chemotherapy of mFOLFOX6 for locally advanced rectal cancer. |
| Date of disclosure of the study information | 2013/12/14 |
| Last modified on | 2020/09/28 17:17:42 |
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Basic information
Public title
The pilot study on surgical safety after neoadjuvant chemotherapy of mFOLFOX6 for locally advanced rectal cancer.
Acronym
The pilot study on surgical safety after neoadjuvant chemotherapy for locally advanced rectal cancer.
Scientific Title
The pilot study on surgical safety after neoadjuvant chemotherapy of mFOLFOX6 for locally advanced rectal cancer.
Scientific Title:Acronym
The pilot study on surgical safety after neoadjuvant chemotherapy for locally advanced rectal cancer.
Region
| Japan |
Condition
Condition
locally advanced rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to evaluate the surgical safety after four courses mFOLFOX6 as neoadjuvant chemotherapy for locally advaced rectal cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
percentage of postoperative complications
Key secondary outcomes
Response rate by preoperative chemotherapy, the safety of preoperative chemotherapy, local recurrence rate, disease-free survival
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
preoperative chemotherapy (4 courses of mFOLFOX6)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The cases histologically diagnosed as rectal cancer by endoscopic biopsy.
2. clinical stage-II or III by preoperative imaging.
3. The main occupation of the primary tumor site is located upper of lower rectum.
4. The age is 20 years old and older and under 75 years old.
5. Performance Status(ECOG) is 0 or 1.
6. No history of surgical treatment for primary tumor.
7. Cases without a history of chemotherapy, radiation, and so on.
8. Cases of major organ function is maintained.
Key exclusion criteria
1. Double cancer
2. Pregnant or lactating women.
3. Patients with a history of colorectal cancer(Excluding mucosal cancer).
4. Patients with peripheral sensory neuropathy(CTCAE v4.0> Grade 1).
5. Patients with infectious disease requiring systemic therapy.
6. Patients with uncontrolable cardiovascular disease.
7. Patients with a history of mental disorder.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinobu Taketomi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Gastroenterological Surgery I
Zip code
Address
North15 West7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5927
taketomi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihiko Takahashi |
Organization
Hokkaido University Hospital
Division name
Gastroenterological Surgery I
Zip code
Address
North15 West7, kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5927
Homepage URL
noripiko@med.hokudai.ac.jp
Sponsor or person
Institute
Gastroenterological Surgery I, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
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
| 2013 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
DOI: 10.1007/s00595-019-01788-8
Number of participants that the trial has enrolled
41
Results
Surgical morbidity (grade 3 or above) occurred in 4 patients (10.5%). Surgery after four courses of mFOLFOX6 chemotherapy can be a safe and promising strategy for patients with locally advanced rectal cancer.
Results date posted
| 2020 | Year | 09 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 05 | Month | 05 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2013 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none remarks
Management information
Registered date
| 2013 | Year | 12 | Month | 12 | Day |
Last modified on
| 2020 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014663
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