UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007492 |
|---|---|
| Receipt number | 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 13:48:12 |
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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
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
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008772
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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