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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027756
Receipt No. R000031746
Scientific Title Single-arm phase II study of induction Gemcitabine+nab-paclitaxel followed by gemcitabine and concurrent radiotherapy for locally advanced pancreatic cancer
Date of disclosure of the study information 2017/07/01
Last modified on 2019/06/16

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Basic information
Public title Single-arm phase II study of induction Gemcitabine+nab-paclitaxel followed by gemcitabine and concurrent radiotherapy for locally advanced pancreatic cancer
Acronym Induction Gem/NabPTX followed by G-CRT for LAPC, sPII
Scientific Title Single-arm phase II study of induction Gemcitabine+nab-paclitaxel followed by gemcitabine and concurrent radiotherapy for locally advanced pancreatic cancer
Scientific Title:Acronym Induction Gem/NabPTX followed by G-CRT for LAPC, sPII
Region
Japan

Condition
Condition Locally advanced pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of induction gemcitabine+nab-paclitaxel followed by gemcitabine and concurrent radiotherapy for locally advanced pancreatic cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall survival (proportion of 2-year survival)
Key secondary outcomes Response rate, CA19-9 response rate, distant metastasis free survival time, progression free survival time, incidecce of adverse events, dose intensity, the rate of treatment related death, the rate of early death, the rate of grade 4 nonhematological toxicity

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 Induction chemotherapy:
Gem plus NabPTX (30-minute IV of nab paclitaxel at 125 mg/m2 followed by 30-minute IV of gemcitabine at 1,000 mg/m2 on day 1,8 and 15, repeated every 4 weeks, for 12 weeks in total)
Followed by Gem and concurrent radiotherapy:
1. Gem(30-minute IV of gemcitabine at 1,000 (maximum) mg/m2 on day 1,8 and 15, repeated every 4 weeks, during radiotherapy
2. Radiotherapy(50.4Gy/28fr, once a day, 5 times a week)
Additional chemotherapy:
Gem plus NabPTX(30-minute IV of nab-paclitaxel at 125 mg/m2 followed by 30-minute IV of gemcitabine at 1,000 mg/m2 on day 1,8 and 15, repeated every 4 weeks until disease progression or unacceptable toxicity.)
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/cytologically proven adenocarcinoma by diagnostic imaging
2) Without obvious organ metastasis (UICC M0) by chest/abdominal/pelvic CT
3) Diagnosed as UICC-T4 or T3 with invasion to common hepatic artery, hepatic artery proper, or portal vein by abdominal and pelvic CT, so judged as unresectable.
4) Without ascites/pleural effusion by chest CT and abdominal/pelvic CT
5) Without active gastrointestinal ulcer
6) Age from 20 to 80 years.
7) Estimated survival more than three months
8) Without interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT and PO2>=80mmHg and %DLCO>=70%
9) ECOG performance status of 0 or 1
10) No peripheral motor/sensory neuropathy
11) No prior surgical treatment for pancreatic cancer
12) Adequate function of major organs
13) Written informed consent
Key exclusion criteria 1) Severe comorbidities (such as heart failure, renal failure, hepatic failure, paresis of intestine, illeus, poorly controlled diabetes(HbA1c>=10%) and poorly controlled hypertension)
2) History of unstable angina pectoris or myocardial infarction within 6 months before registration.
3) Synchronous or metachronous (within 5 years) malignancies except for early cancer.
4) Infectious disease requiring systemic treatment.
5) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy.
6) Severe psychological disorder.
7) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
8) Unavailability of both allergy to bothe of iodine and gadolinium
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryoji Takada
Organization Osaka International Cancer Institute
Division name Hepatobiliary and Pancreatic Oncology
Zip code
Address Otemae, Chuo ku, Osaka, Japan
TEL 06-6945-1181
Email takada-ry@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoji Takada
Organization Osaka International Cancer Institute
Division name Hepatobiliary and Pancreatic Oncology
Zip code
Address Otemae, Chuo ku, Osaka, Japan
TEL 06-6945-1181
Homepage URL
Email takada-ry@mc.pref.osaka.jp

Sponsor
Institute Department of Hepatobiliary and Pancreatic Oncology
Osaka International Cancer Institute
Institute
Department

Funding Source
Organization Department of Hepatobiliary and Pancreatic Oncology
Osaka International Cancer Institute
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 大阪国際がんセンター(大阪府)
Osaka International Cancer Institute, Osaka, Japan

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 01 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
2017 Year 07 Month 01 Day
Date of IRB
2017 Year 07 Month 01 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 14 Day
Last modified on
2019 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031746

Research Plan
Registered date File name
2017/06/28 ③医学研究計画書 inductionLAPC sPII プロトコール vol.1 final.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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