UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024330
Receipt number R000027804
Scientific Title A phase II study of combination chemotherapy of oral tegafur/uracil, leucovorin and bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer
Date of disclosure of the study information 2016/10/07
Last modified on 2016/10/07 14:49:03

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Basic information

Public title

A phase II study of combination chemotherapy of oral tegafur/uracil, leucovorin and bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer

Acronym

A phase II study of UFT/LV and bevacizumab treatment

Scientific Title

A phase II study of combination chemotherapy of oral tegafur/uracil, leucovorin and bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer

Scientific Title:Acronym

A phase II study of UFT/LV and bevacizumab treatment

Region

Japan


Condition

Condition

unresectable metastatic/recurrent colorectal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Surgery in general
Gastrointestinal surgery Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We investigated the efficacy and safety of combination therapy of UFT/LV and Bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Progression free survival

Key secondary outcomes

Overall survival, Time to treatment failure, Overall response rate, Disease control rate, Adverese


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

UFT(300mg/m2/day) and LV(75mg/day) are simultaneously given 3times per day for 5days, followed by 2-day rest. Bevacizumab is administerd by every 3 weeks.

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) Patients with histologically verified adenocarcinoma of the colon and rectum
2) Patients with Unresectable metastatic/recurrent colorectal cancer
3) Patients not appropriate for intensive therapy, such as FOLFOX or FOLFIRI
4) Patents without a previous chemotherapy or radiation therapy
5) Patient's age over 20 years-old
6) ECOG Performance status of 0-2
adequate bone marrow, liver, renal, and cardiac function; no prior radiotherapy, chemotherapy or any molecular targeting therapy for rectal cancer; ; no severe concurrent medical or psychiatric illness; no a known hypersensitivity to the study drugs; and none of the patients were pregnant or lactating.

Key exclusion criteria

1)Patients with a past history of severe drug allergy 2)no other co-existing malignancy or malignancy within the last five years prior to enrollment other than non-melanoma skin cancer or in situ carcinoma of the cervix 3)patients were pregnant or lactating 4)Patients with psychiatric illness 5)Patients with severe co-morbidities (renal failure, liver dysfunction, uncontrolable diabetes mellitus and hypertension, heart failure) 6)Patients with massive ascites or hydrothorax 7)Patients with a symptomatic brain metastasis 8)Patients with abdominal surgery within 28days 9)Patients with perforated disease 10)Patients with thrombosis 11)Patiens with 3+ proteinurea

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kiyoshi Maeda

Organization

Osaka City University Graduate School of Medicine

Division name

Dept of Surgical Oncology

Zip code


Address

Asahimachi, Abeno-ku, Osaka

TEL

06-6645-3838

Email

m1378386@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kiyoshi Maeda

Organization

Osaka City University Graduate School of Medicine

Division name

Dept of Surgical Oncology

Zip code


Address

Asahimachi, Abeno-ku, Osaka

TEL

06-6645-3838

Homepage URL


Email

m1378386@med.osaka-cu.ac.jp


Sponsor or person

Institute

Dept of Surgical Oncology Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Dept of Surgical Oncology Osaka City University Graduate School 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


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

2016 Year 10 Month 07 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

Date of protocol fixation

2016 Year 09 Month 23 Day

Date of IRB


Anticipated trial start date

2016 Year 09 Month 26 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

2016 Year 10 Month 07 Day

Last modified on

2016 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027804


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name