UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015320
Receipt number R000017434
Scientific Title Phase II study of neoadjuvant chemotherapy with SOX + bevacizumab in patients with locally advanced rectal cancer
Date of disclosure of the study information 2014/10/02
Last modified on 2014/10/02 14:25:48

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Basic information

Public title

Phase II study of neoadjuvant chemotherapy with SOX + bevacizumab in patients with locally advanced rectal cancer

Acronym

Phase II study of neoadjuvant chemotherapy with SOX + bevacizumab in patients with locally advanced rectal cancer

Scientific Title

Phase II study of neoadjuvant chemotherapy with SOX + bevacizumab in patients with locally advanced rectal cancer

Scientific Title:Acronym

Phase II study of neoadjuvant chemotherapy with SOX + bevacizumab in patients with locally advanced rectal cancer

Region

Japan


Condition

Condition

Rectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of neoadjuvant chemotherapy with SOX + bevacizumab in patients with locally advanced rectal cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

R0 resection rate

Key secondary outcomes



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

SOX+bevacizumab: 3 courses
Bevacizumab 7.5mg/kg day1
L-OHP 130mg/m2 day1
S-1 80-120mg/day day1 (after dinner)-15(after breakfast) every 3 weeks
SOX: 1 course
L-OHP 130mg/m2 day1
S-1 80-120mg/day day1 (after dinner)-15(after breakfast)

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 adenocarcinoma of the rectum
2) Patients meet all the following criteria by radiological or physical examination before enrollment
i) Main part of the tumor is located in Ra, Rb, P (Rs should be excluded)
ii) Distal border of the tumor is located between peritoneal reflection and anal verge
3) Patients meet either of the following criteria by CT, MRI, or endorectal ultrasound
i) Tumors invade mesorectum beyond rectal muscularis propria
*Tumors which directly invade other organs should be excluded
ii) Lymph node metastases are in the mesorectum (>10 mm in short axis)
* Lymphadenopathy (>5 mm in short axis) in the lateral position should be excluded
4) ECOG Performance Status of 0-1
5) Age of 20 to 80 years
6) Adequate major organ functions within 2 weeks before enrollment, as defined below:
WBC count => 3,000/mm3, <= 12,000/mm3
Neutrophil count => 1,500/mm3
Platelet count => 100,000/mm3
Hemoglobin => 9.0 g/dL
Total bilirubin <= 1.5 x ULN
AST <= 2.5 x ULN
ALT <= 2.5 x ULN
ALP <= 5.0 x ULN
Creatinine <= 1.5 x ULN
CCr => 60 ml/min
urinary protein <= 1+
INR <= 1.5
7) Written informed consent

Key exclusion criteria

1) Any distant metastases
2) Neurological disorder by cerebrovascular disorder within a year before enrollment
3) Symptomatic heart disease or heart disease requiring treatment. Cardiac infarction within a year before enrollment
4) Pleural, peritoneal and pericardial effusion
5) Prior systematic chemotherapy, pelvic irradiation and/or surgery for malignant tumor
6) Active double cancer. Asynchronous double cancer with disease-free duration of 5 years or less. (Including colorectal cancer)
7) Interstitial pneumonia or pulmonary fibrosis
8) Poorly controlled infection
9) Grade 2 or worse peripheral neuropathy
10) Bowel obstruction (Patients with diverting stoma are allowed for enrollment)
11) Poorly controlled diarrhea
12) Confirmed or possible pregnancy, lactation, willingness to become pregnant
(for women), or willingness to have a child (for men)
13) Contraindication of bevacizumab
14) Physician concludes that the patient's participation in this trial is inappropriate.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Furukawa

Organization

Asahikawa Medical University

Division name

Division of Gastroenterologic and General Surgery

Zip code


Address

2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan

TEL

0166-68-2503

Email

f-hiro@asahikawa-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahiro Yamada

Organization

Asahikawa Medical University

Division name

Division of Gastroenterologic and General Surgery

Zip code


Address

2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan

TEL

0166-68-2503

Homepage URL


Email

ridai@asahikawa-med.ac.jp


Sponsor or person

Institute

Asahikawa Medical University

Institute

Department

Personal name



Funding Source

Organization

None

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

2014 Year 10 Month 02 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

Open public recruiting

Date of protocol fixation

2014 Year 03 Month 10 Day

Date of IRB


Anticipated trial start date

2014 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

2014 Year 10 Month 02 Day

Last modified on

2014 Year 10 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017434


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name