UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021206 |
|---|---|
| Receipt number | R000024429 |
| Scientific Title | Feasibility study of perioperative chemotherapy with neoadjuvant GEM+CDDP and adjuvant S-1 for biliary tract cancer |
| Date of disclosure of the study information | 2016/02/25 |
| Last modified on | 2016/02/25 21:07:21 |
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Basic information
Public title
Feasibility study of perioperative chemotherapy with neoadjuvant GEM+CDDP and adjuvant S-1 for biliary tract cancer
Acronym
Feasibility study of perioperative chemotherapy with neoadjuvant GEM+CDDP and adjuvant S-1 for biliary tract cancer
Scientific Title
Feasibility study of perioperative chemotherapy with neoadjuvant GEM+CDDP and adjuvant S-1 for biliary tract cancer
Scientific Title:Acronym
Feasibility study of perioperative chemotherapy with neoadjuvant GEM+CDDP and adjuvant S-1 for biliary tract cancer
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate the feasibility of perioperative chemotherapy with neoadjuvant GEM+CDDP and adjuvant S-1, which is administered for patients with potentially resectable biliary tract cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment completed 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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
GEM+CDDP neoadjuvant chemotherapy is conducted. GEM 1000mg/m2/day and CDDP 25mg/m2/day are intravenously administered on day 1, 8, 22, and 29.
S-1 adjuvant chemotherapy is conducted. S-1 80mg/m2/day is orally administered twice daily for 1 year. Administration of S-1 from day 1 to 28 followed by rest from day 29 to 42 in one cycle.
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. presence of histological or cytological confirmed (adenocarcinoma or adenosquamous carcinoma), or clinically suspected biliary (intrahepatic, hilar/perihilar, or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary cancer)
2. Stage II, III, or IVa biliary tract cancer in the seventh edition of UICC/AJCC staging system
3. with no prior chemotherapy or radiation to biliary tract cancer
4. evaluable lesion was confirmed with imaging studies within 28 day before registration
5. age>=20 years
6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
7. adequate oral intake
8. adequate bone marrow function
White blood cells (WBC)>=3,500/mm3
Neutrophils>=2,000/mm3
Platelet>=100,000/mm3
Hemoglobin>=9.0g/dL
AST<=100IU/L (or 150IU/L under biliary drainage)
ALT<=100IU/L (or 150IU/L under biliary drainage)
serum total bilirubin<=2.0mg/dL (or <=3.0mg/dL under biliary drainage)
serum creatinine<=upper limit of normal range
Alb>=3.0g/dL
9. no abnormal findings by cardiac electrogram within 28 days before registration
10. written informed consent
Key exclusion criteria
1. presence of active double cancer, excluding carcinoma in situ and mucosal carcinoma
2. presence of active infection requiring systemic therapy, excluding viral hepatitis
presence of other cancer except carcinoma in situ
3. accumulated pleural effusion or ascites confirmed in chest CT
4. presence of fever more than 38 degrees Celcius at registration
5. women who are pregnant or during the nursing, women who may be pregnant or are willing to get pregnant, or men who are willing to make thier partner pregnant
6. severe mental disorder
7. uncontrollable diabetes mellitus
8. uncontrollable hypertention
9. history of new-onset unstable angina within 3 weeks, progressive angina, or new-onset myocardial infarction within 6 months before registration
10. presence of severe organ dysfunction including postoperative complication (such as heart failure, renal failure, liver failure, and intestinal paralysis)
11. history of severe drug allegy
12. administered flucytosine, phenytoin, or warfarin potassium
13. uncontrollable diarrhea
14. unsuitable candidate to this study judged by a doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Itano |
Organization
Department of Surgery, Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
Shinanomachi 35, shinjuku-ku
TEL
03-3353-1211
contact@keio-hbpts.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Itano |
Organization
Department of Surgery, Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
Shinanomachi 35, shinjuku-ku
TEL
03-3353-1211
Homepage URL
contact@keio-hbpts.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
non
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
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 | 02 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 25 | 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 | 02 | Month | 25 | Day |
Last modified on
| 2016 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024429
