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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007492
Receipt No. R000008772
Scientific Title Phase II study of chemoradiation with TS-1 / Panitumumab as preoperative treatment in advanced rectal cancer.
Date of disclosure of the study information 2012/03/31
Last modified on 2012/03/13

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Basic information
Public title Phase II study of chemoradiation with TS-1 / Panitumumab as preoperative treatment in advanced rectal cancer.
Acronym Chemoradiation with TS-1 / Panitumumab as preoperative treatment in advanced rectal cancer.
Scientific Title Phase II study of chemoradiation with TS-1 / Panitumumab as preoperative treatment in advanced rectal cancer.
Scientific Title:Acronym Chemoradiation with TS-1 / Panitumumab as preoperative treatment in advanced rectal cancer.
Region
Japan

Condition
Condition advanced rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of neoadjuvant chemoradiotherapy with TS-1 and Panitumumab in patients with locally advanced rectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes complete remission (PCR) rate, Overall survival, Relapse free survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1:80mg/m2 day1-5, day8-12, day15-19, day22-26, day29-day33
Panitumumab: 6mg/kg day1, day15, day29
Radiation:1.8 Gy of consecutive 5 days total 25 fractions, 45.0 Gy

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 proven rectal (adenocarcinoma) cancer.
2) Meet all of the following cases in less than four weeks prior to registration.
Patients who are clinical stage T3-4 by diagnosis (the presence or absence of lymph node metastasis does not matter)
The main site the tumor is occupying is Rb.
The lower edge of the tumor is within 5cm from the anal verge.
3) Patients it is determined that K-ras gene is wild type by mutation analysis.( For patients with mutant K-ras after obtaining informed consent, preoperative chemoradiotherapy combined TS-1 is to conducted for usual treatment.)
4) Patients with no liver metastasis, peritoneal metastasis, and distant metastases.
5) Patients over 20 years of age at registration.
6) Patients who have not been conducted before treatment (radiation therapy, chemotherapy, etc.) against the target site.
7) Patients with adequate main organ function. (To meet all of the following within 14 days prior to the registration.)
WBC >=4,000/mm3
Neutrophil count >=2,000/mm3
Platelet count >=100,000/mm3
Hemoglobin >= 9.0 g / dl
Total bilirubin <= 1.5 mg / dl
(GPT) (GOT); ALT AST <= 2 x times UNL
Serum creatinine <= UNL
Estimated creatinine clearance (by the formula of Cockcroft-Gault) at least 50 ml / min
8) Eastern Cooperative Oncology Group performance status of 0 or 1
9) Patients is possible oral administration of drugs and dietary intake.
10) Patient was explain of this trial and put patient's signature to a document.
Key exclusion criteria 1) Patients with a history of serious drug allergy.
2) Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
3) Patiens receiving flucytosine (a pyrimidine system antifungal agent fluoride).
4) Patients with active infection (fever over 38).
5) Patients with serious complications (intestinal paralysis, intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, uncontrolled hypertension, heart failure, renal failure, liver failure, etc.)
6) Patients with a history of interstitial pneumonia.
7) Patients with ascites, pleural effusion requiring treatment.
8) Patients with gastrointestinal bleeding.
9) Patients with diarrhea.
10) Patients with perforation, penetration.
11) Women with (making) the possibility of pregnancy, pregnant or lactating women. Patients with no intention to contraception.
12) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Hata
Organization Juntendo University Faculty of Medicine
Division name Department of Coloproctological Surgery
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Hata
Organization Juntendo University Faculty of Medicine
Division name Department of Coloproctological Surgery
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL 03-3813-3111
Homepage URL
Email

Sponsor
Institute Juntendo University Faculty of Medicine
Institute
Department

Funding Source
Organization Juntendo University Faculty of Medicine
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 順天堂大学医学部附属順天堂医院

Other administrative information
Date of disclosure of the study information
2012 Year 03 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 Open public recruiting
Date of protocol fixation
2012 Year 02 Month 24 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 03 Month 13 Day
Last modified on
2012 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008772

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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