UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007087
Receipt number R000008346
Scientific Title The Efficacy Study of Neoadjuvant Xelox in Patients with Locally Advanced Lower Rectal Cancer
Date of disclosure of the study information 2012/01/31
Last modified on 2016/10/13 09:51:07

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Basic information

Public title

The Efficacy Study of Neoadjuvant Xelox in Patients with Locally Advanced Lower Rectal Cancer

Acronym

Neoadjuvant Xelox for locally advanced rectal cancer

Scientific Title

The Efficacy Study of Neoadjuvant Xelox in Patients with Locally Advanced Lower Rectal Cancer

Scientific Title:Acronym

Neoadjuvant Xelox for locally advanced rectal cancer

Region

Japan


Condition

Condition

Lower rectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of neoadjuvant chemotherapy using capecitabine and oxaliplatin in patients with locally advanced lower rectal cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

R0 resection rate

Key secondary outcomes

OS, DFS, Local recurrence rate, Rate of sphincter-preservation, Pathologic response rate, Completion rate of postoperative adjuvant chemotherapy, acute toxicity, postoperative complications


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Capecitabine: at a dose of 1000mg/m2 twice daily on days 1-14, 22-35, 43-56
Oxaliplatin: at a dose of 130mg/m2 on days 1, 22 and 43
Surgical resection: 2-6 weeks after the completion of chemotherapy

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. Clinical stage II or III, determined by CT, MRI or EUS
3. Tumor with inferior edge located below peritoneal reflection
4. Without history of chemotherapy or radiotherapy for rectal cancer
5. Eastern Cooperative Oncology Group performance status of 0 or 1
6. Adequate organ function
i) WBC >=3,000/mm3
ii) Neutrophil count >=1,500/mm3
iii) Platelet count >=100,000/mm3
iv) Serum bilirubin <=2.0mg/dl
v) AST <=100IU/l
vi) ALT <=100IU/l
vii) Serum creatinine <=1.5mg/dl
7. Written study-specific informed consent

Key exclusion criteria

1. Lateral node involvement
2. Cancerous fluid
3. Active infectious disease
4. Concomitant malignancy (within 5 years) and double cancer
5. Uncontrolled diabetic
6. Peripheral neuropathy
7. Serious lung disease
8. Clinically significant cardiac disease
9. Pregnant women and nursing mothers, possibly pregnant women, and men attempting to conceive a child
10. Other conditions judged ineligible by physician

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masafumi Nakamura,MD

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Surgery and Oncology

Zip code


Address

3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

TEL

092-642-5437

Email

mnaka@surg1.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Manabe,MD

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Surgery and Oncology

Zip code


Address

3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

TEL

092-642-5440

Homepage URL


Email

manabe@surg1.med.kyushu-u.ac.jp


Sponsor or person

Institute

Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu 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

Surgical Oncology Group of Kyushu and Yamaguchi (SOGKY)

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

2012 Year 01 Month 31 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

No longer recruiting

Date of protocol fixation

2011 Year 12 Month 28 Day

Date of IRB


Anticipated trial start date

2012 Year 02 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

2012 Year 01 Month 17 Day

Last modified on

2016 Year 10 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008346


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name