UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004468 |
|---|---|
| Receipt number | R000005338 |
| Scientific Title | Phase I/II study of gemcitabine/cisplatin/S-1(GCS) combination therapy for patients with advanced biliary tract cancer |
| Date of disclosure of the study information | 2010/11/14 |
| Last modified on | 2020/01/28 09:04:11 |
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Basic information
Public title
Phase I/II study of gemcitabine/cisplatin/S-1(GCS) combination therapy for patients with advanced biliary tract cancer
Acronym
gemcitabine/cisplatin/S-1(GCS) combination therapy for patients with advanced biliary tract cancer
Scientific Title
Phase I/II study of gemcitabine/cisplatin/S-1(GCS) combination therapy for patients with advanced biliary tract cancer
Scientific Title:Acronym
gemcitabine/cisplatin/S-1(GCS) combination therapy for patients with advanced biliary tract cancer
Region
| Japan |
Condition
Condition
Patients with advanced biliary tract cancer that was not amenable to potentially curative surgery or that had recurred after surgery
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the safety of GCS therapy for phase I and efficacy of GCS therapy for phase II.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I
Safety
Phase II
Overall Survival
Key secondary outcomes
Phase II
Toxicity and response rate
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
S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeasted every 2 weeks.
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 cytologically or histologically proved biliary tract cancer
2. age >=20 years
3. PS 0-2
4. No prior history of chemotherapy or radiotherapy. Patients who has undergone adjuvant chemotherapy are eligible if at least 6 months has passed since the last administration.
5. Adequate bone marrow function (neutrophil count >=1,500/mm3, and platelet count >=100,000/mm3), liver function (total bilirubin >=3 mg/dL and AST/ALT >=150 IU/L), and renal function (creatinine clearance >=60 mL/min)
6.No other serious comorbid disease
7.Adequate oral intake
8.Provided written informed consent
Key exclusion criteria
1. Patients with interstitial pneumonia or pulmonary fibrosis
2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months
3. Patients with severe active infection
4. Patients who are pregnant or lactating, or have an intention to get pregnant
5. Patients with a history of severe drug allergy
6. Patients with other serious comorbid disease
7. Patients with mental disease
8. Patients who are judged inappropriate for the entry into the study by the principle doctor
9. Patients with watery diarrhea
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Etsuro Hatano |
Organization
Kyoto University Hospital
Division name
Department of Surgery, Graduate School of Medicine
Zip code
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4349
etsu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Kanai |
Organization
Kyoto University Hospital
Division name
Department of Clinical Oncology and Pharmacogenomics
Zip code
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4349
Homepage URL
kanai@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kansai Hepatobiliary Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 14 | 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
Main results already published
Date of protocol fixation
| 2010 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 28 | Day |
Last modified on
| 2020 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005338
