UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012480 |
|---|---|
| Receipt number | R000014596 |
| Scientific Title | A phase 2 study of combination neoadjuvant chemotherapy with gemcitabine S-1 and leucovorin in patients with borderline and locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2013/12/04 |
| Last modified on | 2019/06/09 14:43:39 |
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Basic information
Public title
A phase 2 study of combination neoadjuvant chemotherapy with gemcitabine S-1 and leucovorin in patients with borderline and locally advanced pancreatic cancer
Acronym
NAC-GSL
Scientific Title
A phase 2 study of combination neoadjuvant chemotherapy with gemcitabine S-1 and leucovorin in patients with borderline and locally advanced pancreatic cancer
Scientific Title:Acronym
NAC-GSL
Region
| Japan |
Condition
Condition
Borderline and Locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of GEM+S-1+LV combination therapy for borderline and locally advanced pancreatic cancers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
R0 resection rate
Key secondary outcomes
Resection rate, Progression free survival, Overall survival, Response rate, Disease control rate, Adverse events, Intra-operative complication, Post-operative complication, Operative time, Postoperative length of stay
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
GEM+S-1+LV combination therapy
GEM:1,000mg/m2, day1
S-1:80mg/day(BSA<1.25/m2)
100mg/day(1.25/m2=<BSA<1.5/m2)
120mg/day(BSA=>1.5/m2), day1-7
LV:50mg/day, day1-7
repeated every 2weeks.
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 pancreatic cancer without prior treatment
2) Patients with pathologically proven pancreatic cancer
3) Borderline and locally advanced pancreatic cancer
4) Without distant metastasis
5) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2
6) Patients of age >= 20 years
7) Patients who can eat
8) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, neutophils >=1,500/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal
9) Estimated survival > 2months
10) Written informed consent is required from all patients.
Key exclusion criteria
1) Patients with systolic blood pressure < 100mmHg
2) Patients with an active concomitant infection
3) Patients with digestive ulcer or gastrointestinal bleeding, severe heart or renal disease
4) Patients with an active pulmonary fibrosis or interstitial pneumonia
5) Patients with severe diarrhea
6) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception
7) Patients with uncontrollable massive pleural effusion or massive ascites
8) Patients with an active concomitant malignancy
9) Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yousuke |
| Middle name | |
| Last name | Nakai |
Organization
The University of Tokyo
Division name
Gastroenterology
Zip code
113-8655
Address
7-3-1, Hongo Bunkyo-ku Tokyo
TEL
03-3815-5411
ynakai-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Saito |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1, Hongo Bunkyo-ku Tokyo
TEL
03-3815-5411
Homepage URL
kesaitou-nii@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo Hospital
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
The University of Tokyo Hospital
Address
7-3-1, Hongo Bunkyo-ku Tokyo
Tel
03-5800-8743
crctky-office@umin.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
| 2013 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007%2Fs12032-018-1158-8
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs12032-018-1158-8
Number of participants that the trial has enrolled
24
Results
Twenty-four patients with PC (21 BR and 3 LA) were enrolled. Response rate and disease control rate of NAC were 17.4 and 87.0%. Grade 3 and 4 toxicities involved neutropenia (34.8%), anorexia (17.4%), and mucositis (17.4%). Serum CA19-9 level decreased by 52.2%. Resection rate was 60.9% after the median of 4 cycles and R0 resection rate was 76.5% in patients undergoing laparotomy. NAC-GSL is a feasible treatment option for BR and LAPC.
Results date posted
| 2019 | Year | 06 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of 24 patients enrolled between January 2014 and December 2016, 23 patients were eligible for the study protocol. One patient was excluded from the analysis because active concomitant malignancy was diagnosed prior to the introduction of GSL therapy.
Participant flow
Two cases did not complete NAC: one case withdrew consent and one had traumatic cerebral hemorrhage unrelated to NAC. In addition, 4 cases were diagnosed as unresectable during NAC due to disease progression: 2 distant metastasis and 2 local disease progression.17 cases (70.8%) who were considered as surgical candidates.
Adverse events
Grade 3 and 4 adverse events developed in 8 cases (34.8%). The major grade 3 and 4 adverse events were neutropenia, anorexia, and mucositis, which were observed in 4 cases (17.4%). Adverse events were manageable after dose reduction and discontinuation of GSL therapy due to toxicity was unnecessary. No toxicity-related death was observed during the preoperative period.
Outcome measures
An R0 resection rate of 76.5% was achieved after the median of 4 courses of NAC-GSL.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 03 | Day |
Last modified on
| 2019 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014596
