UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046618 |
|---|---|
| Receipt number | R000053085 |
| Scientific Title | Phase I/II study of Second-lIne therapy of preoperative cheMoradiothERApy with gemcitabine and nab-paclitaxel for locally advanced pancreatic canceR (SIMERAR trial) |
| Date of disclosure of the study information | 2022/02/10 |
| Last modified on | 2022/05/23 06:44:14 |
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Basic information
Public title
Phase I/II study of Second-lIne therapy of preoperative cheMoradiothERApy with gemcitabine and nab-paclitaxel for locally advanced pancreatic canceR (SIMERAR trial)
Acronym
Phase I/II study of Second-lIne therapy of preoperative cheMoradiothERApy with gemcitabine and nab-paclitaxel for locally advanced pancreatic canceR (SIMERAR trial)
Scientific Title
Phase I/II study of Second-lIne therapy of preoperative cheMoradiothERApy with gemcitabine and nab-paclitaxel for locally advanced pancreatic canceR (SIMERAR trial)
Scientific Title:Acronym
Phase I/II study of Second-lIne therapy of preoperative cheMoradiothERApy with gemcitabine and nab-paclitaxel for locally advanced pancreatic canceR (SIMERAR trial)
Region
| Japan |
Condition
Condition
Patients with locally advanced pancreatic cancer (BR-A or UR-LA) scheduled for pancreatic resection
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of present study is to confirm the safety and efficacy of chemoradiotherapy using gemcitabine plus nab-paclitaxel (GEM+nab-PTX) as preoperative chemoradiotherapy for locally advanced pancreatic cancer after primary chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase I study: Incidence of dose-limiting toxicities (DLT)
Phase II study: 2-year survival rate
Key secondary outcomes
Phase I study:
Response rate
Disease control rate
Safety (incidence and severity of adverse events)
Phase II study:
Overall survival
Progression-free survival
Response rate
Disease control rate
Tumor marker decrease rate
Surgical procedure
Intraoperative blood loss
Operation time
Resection rate
R0 resection rate
Incidence of postoperative pancreatic fistula
Postoperative hemorrhage
Incidence of DGE
Incidence of diarrhea
Other postoperative complications
Safety (incidence and severity of adverse events)
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
Preoperative chemoradiotherapy using gemcitabine plus nab-paclitaxel for locally advanced pancreatic cancer after primary chemotherapy.
gemcitabine plus nab-paclitaxel therapy: gemcitabine plus nab-paclitaxel are administered intravenously on days 1 and 8 of a 21-day course. This is done for two courses.
radiation: 1.8 Gy per day, 5 times a week, total of 28 fractionation (total dose 50.4 Gy/28 fr).
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) Pancreatic cancer (invasive ductal carcinomas) diagnosed by imaging and pathological examination
2) No evidence of distant metastasis
3) Patients diagnosed with BR-A or UR-LA pancreatic cancer, who have received at least 3 courses of gemcitabine plus nab-paclitaxel as primary chemotherapy, whose efficacy is judged to be CR/PR/SD, and who are technically considered to be resectable and are planning to undergo surgery.
4) Age: between 20 and 80 years old
5) Performance status (ECOG): 0 or 1
6) Tumor is measurable on imaging CT
7) No history of chemotherapy, hormonal therapy, or molecular targeted therapy other than the above
8) No history of radiation therapy to the abdomen
9) Appropriate biliary drainage is performed in cases of obstructive jaundice.
10) No direct invasion of the gastrointestinal tract on imaging findings
11) No evidence of concurrent cancer of other organs
12) adequate major organ function
(1) Leukocyte count: >=3500 /mm3, <12000 /mm3
(2) Neutrophil count: >=2000 /mm3
(3) Hemoglobin: >=9.0 g/dL
(4) Platelet count: >=100000 /mm3
(5) Total bilirubin: <=2.0 mg/dL (<=3.0 mg/dL: patients undergoing drainage for obstructive jaundice)
(6) AST: <=150 U/L, ALT: <=150 U/L
(7) Creatinine: <=1.2 mg/dL
(8) Creatinine clearance: >=50 mL/min
13) Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria
1) Active multiple cancers
2) Patients whose dose of GEM+nab-PTX in primary chemotherapy was reduced to less than 600 mg/m2 of GEM or less than 75 mg/m2 of nab-PTX
3) Patients who were refractory or intolerant to primary GEM+nab-PTX and were switched to other chemotherapy
4) Infection or inflammation that requires systemic treatment
5) Fever of 38.0 degrees Celsius higher at the time of registration
6) Allergy or contraindication to gemcitabine or paclitaxel
7) History of severe drug hypersensitivity or drug allergy
8) Allergy to contrast media
9) History of serious heart disease
10) History of serious underlying diseases (poorly controlled diabetes, renal failure, liver cirrhosis, etc.)
11) Poorly controlled ascites or pleural effusion
12) Active gastrointestinal bleeding requiring repeated blood transfusions.
13) Diarrhea (more than 4 times a day or watery stools)
14) Poorly controlled cancer pain
15) Pulmonary fibrosis or interstitial pneumonia with obvious or clinical findings on imaging
16) Lung field enters the radiation field
17) Pregnant or lactating women or those with the potential (intention) to become pregnant
18) Severe psychological or neurological disease
19) Unable to give consent to participate in this study
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Fujii |
| Middle name | |
| Last name | Tsutomu |
Organization
Faculty of Medicine, Academic Assembly, University of Toyama
Division name
Department of Surgery and Science
Zip code
9300194
Address
2630, Sugitani, Toyama
TEL
076-434-7331
fjt@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Kazuto |
| Middle name | |
| Last name | Shibuya |
Organization
Faculty of Medicine, Academic Assembly, University of Toyama
Division name
Department of Surgery and Science
Zip code
9300194
Address
2630, Sugitani, Toyama
TEL
076-434-7331
Homepage URL
shibuyak@med.u-toyama.ac.jp
Sponsor or person
Institute
Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama
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
Center for Clinical Research, Toyama University Hospital
Address
2630, Sugitani, Toyama
Tel
076-434-7331
rinri@adm.u-toyama.ac.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 10 | 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
| 2021 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 13 | Day |
Last modified on
| 2022 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053085
