UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032534
Receipt number R000037010
Scientific Title Efficacy and safety of laparoscopic surgery for resectable locally recurrent rectal cancer
Date of disclosure of the study information 2018/05/09
Last modified on 2020/05/10 09:46:17

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Basic information

Public title

Efficacy and safety of laparoscopic surgery for resectable locally recurrent rectal cancer

Acronym

Efficacy and safety of laparoscopic surgery for resectable locally recurrent rectal cancer

Scientific Title

Efficacy and safety of laparoscopic surgery for resectable locally recurrent rectal cancer

Scientific Title:Acronym

Efficacy and safety of laparoscopic surgery for resectable locally recurrent rectal cancer

Region

Japan


Condition

Condition

Resectable local pelvic recurrence of rectal cancer

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficiency and safety of neoadjuvant chemoradiotherapy with capecitabine followed by laparoscopic radical surgery for locally recurrent rectal malignant tumor

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Safety (operative time, intraoperative bleeding, conversion to open surgery, incidence of complication after surgery, hospitalized days after surgery

Key secondary outcomes

R0 resection rate
TRG: tumor regression grade
pCRM: pathological circumferential resection margin
QOL: quality of life after surgery
OS: overall survival
RFS: recurrence free survival
LFS: local recurrence 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

Maneuver

Interventions/Control_1

Neoadjuvant chemoradiothearpy with capecitabine followed by laparoscopic surgery
Capecitabine; treatment dose was decided by body mass index

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: R0 resection was performed by the initial surgery for rectal malignant tumor
2: The diagnosis of recurrent rectal cancer was proven with tissue biopsy, or with medical imaging.
3: The recurrent tumor should be localized without extra-pelvic metastasis, distant metastasis was absent.
4: Patients had to have ECOG performance status of 0 or 1.
5: Written informed consent was obtained from all patients before enrollment.

Key exclusion criteria

1: Unresectable: tumor extension into S1 nerve, external iliac artery,obturator internus muscle
2: Patients with serious complications
3: Patients who would not complete this study according to surgeon's decision

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Ikeda
Middle name
Last name Masataka

Organization

Hyogo College of Medicine

Division name

Division of Lower GI Surgery, Department of Surgery

Zip code

663-8501

Address

1-1Mukogawa-cho, Nishinomiya, Hyogo, Japan

TEL

0798-45-6372

Email

ms-ikeda@hyo-med.ac.jp


Public contact

Name of contact person

1st name Kimura
Middle name
Last name Kei

Organization

Hyogo College of Medicine

Division name

Division of Lower GI Surgery, Department of Surgery

Zip code

663-8501

Address

1-1Mukogawa-cho, Nishinomiya, Hyogo, Japan

TEL

0798-45-6372

Homepage URL


Email

k-kimura@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hyogo College of Medicine

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

Hyogo College of Medicine

Address

1-1Mukogawa-cho, Nishinomiya, Hyogo, Japan

Tel

0798-45-6372

Email

k-kimura@hyo-med.ac.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

2018 Year 05 Month 09 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

2018 Year 05 Month 09 Day

Date of IRB


Anticipated trial start date

2018 Year 05 Month 09 Day

Last follow-up date

2023 Year 05 Month 31 Day

Date of closure to data entry

2023 Year 05 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 09 Day

Last modified on

2020 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037010


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name