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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | C000000271 |
Receipt No. | R000000342 |
Scientific Title | A phase II study of cisplatin with TS-1 for patients with cancer of primary unknown |
Date of disclosure of the study information | 2005/10/31 |
Last modified on | 2018/03/04 |
Basic information | ||
Public title | A phase II study of cisplatin with TS-1 for patients with cancer of primary unknown
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Acronym | A phase II study of cisplatin with TS-1 | |
Scientific Title | A phase II study of cisplatin with TS-1 for patients with cancer of primary unknown
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Scientific Title:Acronym | A phase II study of cisplatin with TS-1 | |
Region |
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Condition | ||
Condition | cancer of primary unknown | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the effect of cisplatin with TS-1 for patients for patients with cancer of primary unknown
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Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Response Rate |
Key secondary outcomes | Safety Profile |
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 |
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Interventions/Control_1 | Chemotherapy | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | The eligibility criteria are as follows;(1) histologic or cytologic confirmation of metastatic cancer with unknown primary site (2) not subject to radiation or surgery(3) measurable or evaluable lesions; (4) no previous treatments (5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 (6)age more than 20 (7) adequate organ function (8) written informed consent |
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Key exclusion criteria | The exclusion criteria are as follows: 1.female adenocarcinoma with axillary lymph nodes swelling only, or pelvic cavity endolymph nodes only 2.squamous carcinoma with cervical lymph nodes swelling only, or inguen lymph nodes only 3.patients with germ cell tumor or have characteristic of neuroendocrine tumor 4.patients with high level of PSA in serum or tumor (1) severe infection or other severe complications (such as gastrointestinal bleeding, heart disease) (2) symptomatic brain metastasis (3) patients who carried out bone marrow transplantation (4) patients who carried out peripheral blood stem cell transplantation (5) drug allergy (6) pregnancy or lactating (7) male patients who hope for pregnancy (8) uncontrollable diabetes mellitus |
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Target sample size | 45 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kinki University School of Medicine | ||||||
Division name | Department of Medical Oncology | ||||||
Zip code | |||||||
Address | 377-2, Ohno-Higashi, Osakasayama, Osaka | ||||||
TEL | 072-366-0221 | ||||||
kuratat@hirakata.kmu.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kinki University School of Medicine | ||||||
Division name | Department of Medical Oncology | ||||||
Zip code | |||||||
Address | 377-2, Ohno-Higashi, Osakasayama, Osaka | ||||||
TEL | 072-366-0221 | ||||||
Homepage URL | |||||||
t-kurata@med.kindai.ac.jp |
Sponsor | |
Institute | Department of Medical Oncology, Kinki University School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Department of Medical Oncology, Kinki University School of Medicine |
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 | |
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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 | Published |
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 | Main results already published | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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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=R000000342 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |