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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000027633 |
Receipt No. | R000031637 |
Scientific Title | Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2018/01/31 |
Basic information | ||
Public title | Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment | |
Acronym | Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment | |
Scientific Title | Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment | |
Scientific Title:Acronym | Randomized phase II study of neoadjuvant chemoradiotherapy (S-1+radiation) for resectable pancreatic cancer with less than 180 degree portal vein abutment | |
Region |
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Condition | ||
Condition | resectable pancreatic cancer with less than 180 degree portal vein abutment | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the local control efficacy of neoadjuvant chemoradiotherapy with S-1 for resectable pancreatic cancer with less than 180 degree portal vein abutment. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Local recurrence rate within 2 years after surgery |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |||
No. of arms | 2 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | ArmA; Neoadjuvant chemotherapy group
S-1: 80mg/m2/day, 2 weeks administration followed by 1 week withdrawl and 2 weeks administration, for a total of 5 weeks. Radiotherapy: 1.8 Gy/day, 28days, a total of 50.4Gy |
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Interventions/Control_2 | Arm B: Surgery group without neoadjuvant therapy | ||
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1) Patients diagnosed with pancreatic cancer
(2) Patients without distant metastasis, M0 (UICC8th TNM) (3) Resectable pancreatic cancer by NCCN guideline (Version 2. 2016) with less than180 degree portal vein abutment and without encasement (4) ECOG PS 0-1 (5) No prior therapy for pancreatic cancer (6) Patients without active cancer of other organs (7) Patients who can intake orally (8) Main organs function test almost within normal range (9) Patients who fully understand the study procedures and consent the document voluntary after an adequate explanation |
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Key exclusion criteria | (1) Patients who have allergies to S-1
(2) Patients who have active infection (3) Patients with active peptic ulcer (4) Patients with ileus (5) Patients with Grade>=2 diarrhea according to CTCAE v4.0 (6) Patients with uncontrolled ascites or pleural effusion (7) Patients with flucytosine, phenytoin, or warfarin potassium administration (8) Patients with serious comorbid conditions (9) Patients with pregnancy (10) Patients with serious psychiatric diseases (11) Patients who were deemed inappropriate for medical reasons |
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Target sample size | 56 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Nagoya University, Graduate School of Medicine
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Division name | Gastroenterorogical Surgery | ||||||
Zip code | |||||||
Address | 65 Tsurumai-cho Showa-ku Nagoya city | ||||||
TEL | 052-744-2253 | ||||||
ykodera@med.nagoya-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Nagoya University, Graduate School of Medicine | ||||||
Division name | Gastroenterorogical Surgery | ||||||
Zip code | |||||||
Address | 65 Tsurumai-cho Showa-ku Nagoya city | ||||||
TEL | 052-744-2253 | ||||||
Homepage URL | |||||||
suguru@med.nagoya-u.ac.jp |
Sponsor | |
Institute | Nagoya University, Graduate School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Nagoya University, Graduate School of Medicine |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
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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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031637 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |