UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012559
Receipt No. 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 (Ver. 8)

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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
Email 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
Email noripiko@med.hokudai.ac.jp

Sponsor
Institute Gastroenterological Surgery I, Hokkaido University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014663