UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024154 |
|---|---|
| Receipt number | R000027812 |
| Scientific Title | Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with borderline resectable pancreatic cancer. |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2023/10/01 13:19:45 |
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Basic information
Public title
Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy
for patients with borderline resectable pancreatic cancer.
Acronym
Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy
for patients with BRPC.
Scientific Title
Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy
for patients with borderline resectable pancreatic cancer.
Scientific Title:Acronym
Phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy
for patients with BRPC.
Region
| Japan |
Condition
Condition
Invasive ductal adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy on survival time of NAC-GA therapy as neoadjuvant chemotharpy for borderline resectable pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival time from the first day of protocol therapy
Key secondary outcomes
1.Recurrence free survival from the first day of protocol therapy
2.Safety of the protocol therapy(Adverse effect)
3.Morbidity based on Clavien Dindo classification of more than Grade3
4.Response rate, preoperative/postoperative tumor marker (CA19-9, CEA), rate of mornalization, reduction rate of SUVmax value on PET-CT(limited only for PET-CT available institutions)
5.Chemotherapeutic effect grade based on Evans classification.
6.Resection rate
7.R0 resection rate
8.Surgical data(operative time, blood loss,transfusion, postoperative hospital day)
9.The overall morbidity rates(Reoperation, rate of re-admission, mortality)
10.Number of patient rate in postoperative adjuvant therapy(entry rate, completion rate)
11.Dose intensity
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
neoadjuvant chemotherapy 2 courses of NAC-GA
1.nab-paclitaxel (Day1,8,15) 125mg/m2 30 min div administration
2.Gemcitabine (Day1,8,15) 1,000mg/m2 30 min div administration
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 or cytologically diagnosed as pancreatic adenocarcinoma, and consistent with NCCN guideline (Version 2. 2016) borderline resectable-arterial, borderline resectable-venous
2.case with measurable lesion
3.First line treatment
4.PS(ECOG)0-1
5.>=20 years old and <80 years old
6.The following criteria must be satisfied in laboratory tests within 14 days of registration
WBC count<=12,000/mm3
Neutrophil count>=1,500/mm3
Hb>=9.0g/dl
Plt >=100,000/mm3
T.Bil <2.0mg/dl (<3=.0mg/dl in biliary drainage case)
Serum Cr<=upper limits of normal (ULN)
AST, ALT<=2.5xULN
7. Written informed consent to participate in this study
Key exclusion criteria
1.Severe drug hypersensitivity
2.Multiple primary cancers within 5 years
3.Severe infection
4.With grade2 or more severe peripheral neuropathy
5.Interstitial pneumonia or pulmonary fibrosis
6.With uncontrollable pleural effusion or ascites
7.With uncontrollable diabetes mellitus
8.With uncontrollable heart failure, angina, hypertension, arrhythmia
9.With severe neurological/psychological symptoms
10.With watery diarrhea
11.Pregnant or lactating women or women with unknown or suspected pregnancy
12.Inappropriate patients for entry on this study in the judgement of the investigator
13.Diagnosed as Resectable/Unresectable pancreatic carcinoma on NCCN guideline (Version 2.2016)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Yamaue |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
Kimiidera 811-1, Wakayama City
TEL
073-441-0613
yamaue-h@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Okada |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8510
Address
Kimiidera 811-1, Wakayama City
TEL
073-441-0613
Homepage URL
okada@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
TAIHO PHARMACEUTICAL CO., LTD
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Wakayama Medical University
Address
Kimiidera 811-1, Wakayama City
Tel
073-447-2300
warinri@wakayama-med.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
和歌山県立医科大学附属病院（和歌山県）、京都府立医科大学附属病院（京都府）、関西医科大学附属病院（大阪府）、大阪医科大学附属病院（大阪府）、神戸大学附属病院（兵庫県）、大阪大学附属病院（大阪府）、大阪市立大学附属病院（大阪府）、奈良県立医科大学附属病院（奈良県）、近畿大学附属病院（大阪府）、名古屋大学附属病院（愛知県）、広島大学附属病院（広島県）、熊本大学附属病院（熊本県）、弘前大学附属病院（青森県）、京都大学附属病院（京都府）、千葉大学附属病院（千葉県）、滋賀医科大学附属病院（滋賀県）、兵庫医科大学附属病院（兵庫県）、岐阜大学附属病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Oncology. 2017;93(5):343-346. doi: 10.1159/000478660. Epub 2017 Jul 19. PMID: 28719890.
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
62
Results
Primary endpoint: Overall survival (median) 25.2 months.
Secondary endpoints:
Recurrence-free survival: 12.3 months
Response rate of preoperative chemotherapy: 61 target cases, antitumor effect CR 0, PR 17, SD 36, PD 8, NE 0. 17 successful cases, 27.9% response rate
Primary endpoint: Overall survival (median) 25.2 months.
Secondary endpoints:
Recurrence-free survival: 12.3 months
Results date posted
| 2023 | Year | 04 | Month | 01 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The manuscripr has been already submitted, however it is still not accepted yet.
Date of the first journal publication of results
Baseline Characteristics
Expression of numbers: median [min, max] or N (%)
Target cases: n=62
Sex: Man35 (56.5%), Woman27 (43.5%)
Age (years)69 [45,80]
Height(cm) 160.8 [140.2,176.0]
Body weight(kg) 54.8 [30.0,77.7]
BMI 21.5 [14.3,33.4]
PS
0 57 (91.9%)
1 5 (8.1%)
2 0 (0.0%)
3 0 (0.0%)
4 0 (0.0%)
Tumor location
Head 42 (67.7%)
Body 19 (30.6%)
Tail 1 (1.6%)
Tumor maximum size (mm) 28.1 [15.7,61.0]
Diagnosis of borderline crteria
Arterial 24 (38.7%)
Venous 23 (37.1%)
Both 15 (24.2%)
TMN classification
T factor
T1 0 (0.0%)
T2 0 (0.0%)
T3 36 (58.1%)
T4 26 (41.9%)
Tx 0 (0.0%)
N factor
N0 48 (77.4%)
N1 14 (22.6%)
NX 0 (0.0%)
M factor
M0 62 (100.0%)
M1 0 (0.0%)
MX 0 (0.0%)
Stage
IIA 27 (43.5%)
IIB 9 (14.5%)
III 26 (41.9%)
Participant flow
Preoperative chemotherapy: 62 cases, Turned out to be ineligible n=1, 1 case died after 2 courses of chemotherapy (with judgment of therapeutic effect), Stopped chemotherapy n=4: Adverse events n=2, Progressive disease n=0, Refused further chemotherapy n=0, Other reasons n=2. 43 cases underwent pancreatectomy after completion of chemotherapy, 2 cases underwent pancreatectomy after chemotherapy was discontinued, and 0 cases underwent unresectable surgery. 61 cases of treatment effect judgment among protocol implementation cases.
Adverse events
Treatment related death (TRD): Two patients died with exacerbation from pneumonia. One patient has a history of irradiation therapy for past esophageal cancer. The other patient has emphysema without evaluation of exclusion criteria #13, and is treated as ineligible case after enrollment.
Otherwise, other adverse events were generally within the expected range.
Outcome measures
Primary endpoint: Overall survival (median)
Secondary endpoints:
Recurrence-free survival, Response rate of preoperative chemotherapy, Surgical complication rate of Grade IIIa or higher according to the Clavien-Dindo classification for all postoperative hospital stays, Normalization rate of tumor markers, PET-CT examination Reduction rate of tumor SUVmax value (mean [95% CIs]), Histological therapeutic effect, Resection rate, Radical resection rate (R0 rate).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027812
