UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027756 |
|---|---|
| Receipt number | 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 | 2023/06/19 12:58:28 |
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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 | Ryoji |
| Middle name | |
| Last name | Takada |
Organization
Osaka International Cancer Institute
Division name
Hepatobiliary and Pancreatic Oncology
Zip code
541-8567
Address
Otemae, Chuo ku, Osaka, Japan
TEL
06-6945-1181
takada-ry@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Ryoji |
| Middle name | |
| Last name | Takada |
Organization
Osaka International Cancer Institute
Division name
Hepatobiliary and Pancreatic Oncology
Zip code
541-8567
Address
Otemae, Chuo ku, Osaka, Japan
TEL
06-6945-1181
Homepage URL
takada-ry@mc.pref.osaka.jp
Sponsor or person
Institute
Department of Hepatobiliary and Pancreatic Oncology
Osaka International Cancer Institute
Institute
Department
Personal name
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
Institutional Review board of Osaka international cancer institut
Address
Otemae, Chuo ku, Osaka, Japan
Tel
06-6945-1181
rinri01@opho.jp
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
40
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
No longer 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
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 21 | Day |
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
| 2023 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.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 |
