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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000004410 |
Receipt No. | R000005242 |
Scientific Title | Randomized phase III study of adjuvant chemotherapy with combination therapy of gemcitabine and S-1 vs. gemcitabine alone in patients with resected pancreatic cancer (JSAP-04) |
Date of disclosure of the study information | 2010/10/20 |
Last modified on | 2016/04/19 |
Basic information | ||
Public title | Randomized phase III study of adjuvant chemotherapy with combination therapy of gemcitabine and S-1 vs. gemcitabine alone in patients with resected pancreatic cancer (JSAP-04) | |
Acronym | Phase III study of gemcitabine and S-1 combination therapy for resected pancreatic cancer | |
Scientific Title | Randomized phase III study of adjuvant chemotherapy with combination therapy of gemcitabine and S-1 vs. gemcitabine alone in patients with resected pancreatic cancer (JSAP-04) | |
Scientific Title:Acronym | Phase III study of gemcitabine and S-1 combination therapy for resected pancreatic cancer | |
Region |
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Condition | |||
Condition | Resected pancreatic cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate superiority in survival of adjuvant chemotherapy with gemcitabine and S-1 against gemcitabine alone in patients with resected pancreatic cancer |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | Overall survival |
Key secondary outcomes | Relapse-free survival
Incidence of adverse events |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | YES |
Institution consideration | Institution is considered as adjustment factor in dynamic allocation. |
Blocking | NO |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Patients receive gemcitabine (1,000 mg/m2, days 1, 8 and 15) every 4 weeks. This cycle is repeated for six months or until relapse is confirmed. | |
Interventions/Control_2 | Patients receive gemcitabine (800 mg/m2, day 1) plus S-1 (65 mg/m2/day, days 1-7) every 2 weeks. This cycle is repeated for six months or until relapse is confirmed. | |
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) Histologically proven invasive ductal carcinoma of the pancreas
2) Macroscopically curative resection (R0, R1) 3) No metastasis 4) No history of prior chemotherapy or radiotherapy for pancreatic cancer 5) Age 20 to 79 years 6) ECOG performance status of 0 or 1 7) Adequate organ function 8) Written informed consent 9) Within 10 weeks after surgery |
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Key exclusion criteria | 1) History of serious complications related to surgery
2) Patients under treatment with phenytoin, warfarin potassium or flucytosine. 3) Uncontrolled watery diarrhea 4) Sever mental disorder 5) Active infection 6) Serious complications 7) Pulmonary fibrosis or interstitial pneumonia 8) Clinically significant pleural effusions or ascites 9) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 2 years or less) 10) History of chemotherapy or radiotherapy for other malignant disease within one year 11) Unable to receive contrast enhanced CT nor MRI due to allergic reaction to contrast medium 12) Pregnant females, possibly pregnant females, females wishing to become pregnant, and males that are currently attempting to produce a pregnancy 13) Inadequate physical condition, as diagnosed by primary physician |
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Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Cancer Center Hospital | ||||||
Division name | Hepato-Biliary-Pancreatic Surgery Division | ||||||
Zip code | |||||||
Address | 5-1-1, Tsukiji, Chuo-ku, Tokyo | ||||||
TEL | 03-3542-2511 | ||||||
tkosuge@ncc.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Cancer Center Hospital | ||||||
Division name | Hepatobiliary and Pancreatic Oncology Divison | ||||||
Zip code | |||||||
Address | 5-1-1, Tsukiji, Chuo-ku, Tokyo | ||||||
TEL | 03-3542-2511 | ||||||
Homepage URL | http://mhlw-grants.niph.go.jp/ | ||||||
hiueno@ncc.go.jp |
Sponsor | |
Institute | Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer (JSAP) |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Health, Labour and Welfare |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
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 | |
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 |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
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=R000005242 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |