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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 | UMIN000004422 |
Receipt No. | R000005282 |
Scientific Title | Preoperative chemoradiation therapy combined with peptide vaccination for T3-pancreatic cancer: prospective phase I/II study |
Date of disclosure of the study information | 2010/10/20 |
Last modified on | 2018/04/26 |
Basic information | ||
Public title | Preoperative chemoradiation therapy combined with peptide vaccination for T3-pancreatic cancer: prospective phase I/II study | |
Acronym | Preoperative multimodal treatment for pancreatic cancer | |
Scientific Title | Preoperative chemoradiation therapy combined with peptide vaccination for T3-pancreatic cancer: prospective phase I/II study | |
Scientific Title:Acronym | Preoperative multimodal treatment for pancreatic cancer | |
Region |
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Condition | ||
Condition | T3(UICC)-pancreatic cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the safety and efficacy of preoperative chemoradiation therapy combined with peptide vaccination for resectable pancreatic cancer patient. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Phase I,II |
Assessment | |
Primary outcomes | Safety
Disease free survival |
Key secondary outcomes | Overall survival,
Histopathological and immunological response, pattern of recurrence |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Non-randomized |
Randomization unit | |
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 | Preoperative gemcitabine-based chemoradiation therapy with peptide vaccination | |
Interventions/Control_2 | Preoperative gemcitabine-based chemoradiation therapy without peptide vaccination | |
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 | Resectable Pancreatic cancer ; T3 of UICC TNM classification of malignant tumours 7th edition). Histological or cytological confirmation as pancreatic adenocarcinoma
is required. No contraindication for gemcitabine-based chemoradiation therapy. |
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Key exclusion criteria | Liver, renal dysfunction, severe coronary disease.
Unresectable pancreatic cancer, including borderline resectable cases. |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Osaka Medical Center for Cancer & Cardiovascular Diseases | ||||||
Division name | Department of Gastroenterological surgery | ||||||
Zip code | |||||||
Address | 1-3-3, Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan | ||||||
TEL | 06-6945-1181 | ||||||
takahasi-hi@mc.pref.osaka.jp |
Public contact | |||||||
Name of contact person |
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Organization | Osaka Medical Center for Cancer & Cardiovascular Diseases | ||||||
Division name | Department of Gastroenterological surgery | ||||||
Zip code | |||||||
Address | 1-3-3, Nakamichi, Higashinari-ku, Osaka, 537-8511, Japan | ||||||
TEL | 06-6972-1181 | ||||||
Homepage URL | |||||||
takahasi-hi@mc.pref.osaka.jp |
Sponsor | |
Institute | Department of Gastroenterological Surgery, Osaka Medical Center for cancer & Cardiovascular Diseases |
Institute | |
Department |
Funding Source | |
Organization | Osaka Medical Center for cancer & Cardiovascular Diseases |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Human Genome Center, Institute of Medical Science, University of Tokyo |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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=R000005282 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |