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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004009
Receipt No. R000004818
Scientific Title Phase I trial of Nedaplatin+5FU+Doc combination therapy for Recurrence or Metastatic of Esophagus cancer
Date of disclosure of the study information 2010/08/06
Last modified on 2010/08/06

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Basic information
Public title Phase I trial of Nedaplatin+5FU+Doc combination therapy for Recurrence or Metastatic of Esophagus cancer
Acronym Phase I trial of Nedaplatin+5FU+Doc combination therapy for Recurrence or Metastatic of Esophagus cancer
Scientific Title Phase I trial of Nedaplatin+5FU+Doc combination therapy for Recurrence or Metastatic of Esophagus cancer
Scientific Title:Acronym Phase I trial of Nedaplatin+5FU+Doc combination therapy for Recurrence or Metastatic of Esophagus cancer
Region
Japan

Condition
Condition Esophagus cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We have a recurrence symptom example or distant metastasis and review nedaplatin for the esophageal cancer that radical radiotherapy is impossible and 5FU and decision of a recommendation dosage of Doc medical treatment and influence to give to safety and pharmacokinetics of both medicine.
Furthermore, we put it together and perform examination about antitumor effect of this combination therapy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Decision of a recommended dosage
Key secondary outcomes

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 2010/6-2013/5
nedaplatin 70-90mg/m2
Doc 30-35mg/m2
5FU 800mg/m2/day
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)Primary tumor is either of cervical part / thoracic esophagus.
2)It is diagnosed as either of a squamous cell carcinoma, an adenosquamous carcinoma, adenocarcinoma for histopathology.
3)It is unresectable esophageal cancer or oesophageal carcinoma recurrent, and, at the time of registration, a thing and the unresectable esophageal cancer that an operation, radiotherapy, adaptation of chemoradiotherapy judged not to be it satisfy 1-3 entirely, and oesophageal carcinoma recurrent satisfy 3.
1,Clinical invasion depth is cT1-cT4.
2,Distant metastasis falls under following neither.
i)Distant metastasis part is only a cervical lymph node.
ii)Distant metastasis part is only celiac artery circumference lymph gland.
3,It is slightness whether there is not passage disorder, and ingestion is capable enough.
4)ECOG Performance status is 0 or 1.
5)There are not chemotherapies, chemoradiotherapy and a history of radiotherapy for every cancer class including esophageal cancer.
6)We satisfy all the following conditions.
that examination of an equal day two weeks of registration day ago permits it
(1)4,000 white blood corpuscle >= /mm3 and 12,000 <= /mm3
(2)2,000 mature granulocyte >= /mm3
(3)100,000 blood platelet >= /mm3
(4)Haemoglobin >= 9.0g/dL
(5)100 AST <= IU/L
(6)100 ALT <= IU/L
(7)Bilirubin total <= 1.2mg/dL
(8)Creatinine <= 1.5mg/dL
(9)A hepatitis B surface antigen is negative on examination before registration
(10)SpO2 >= 95% (room air)
(11)12 resting inductive electrocardiograms within 28th before registration do not show abnormal findings to need treatment.
7)There are not metastases to brain having a symptom.
8)We do not show the moderate above-mentioned pleural effusion, ascitic fluid.
9)About final examination participation, an agreement by a document from the person himself is obtained.
Key exclusion criteria 1)
During treatment or diabetes mellitus inadequate control (HbA1c merges) doing more than 6.5% with an aim by consecutive use of insulin.
2)
The patient having active multiple primary cancer (synchronism multiple primary cancer and a having sound health period, metachronous multiple primary cancer within five years).
But healing and judged carcinoma in situ (carcinoma in situ) or lesion of intramucosal carcinoma equivalency cannot include.In active multiple primary cancer by local treatment.
3)
It is the patient having an anaphylactic history for DOC, CDGP, 5-FU and polysorbate "80" component pharmaceutical.
4)
We have active bacteria and fungal infection.
(we have pyrexia more than 38 degrees Celsius, and bacterial infection is proved on an imaging or bacteriologic examination)
5)
The patient who has consecutive systemic therapy (in internal use or a vein) of steroid.
6)
Regardless of presence of a cause, it is motor paralysis, the patient having peripheral neuropathy (more than CTCAE v3.0, Grade 1).
7)
The patient who shows dropsy (more than CTCAE v3.0, Grade 1) regardless of presence of cause.
8)
The patient having the interstitial pneumonia that is apparent by chest X-rays or CT or pulmonary fibrosis.
9)
The patient whom we merge psychosis or neurologic manifestation, and it is judged to have difficulty with participation to an examination.
10)
During the pregnancy or a pregnant female patient we are possible or are nursing.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name shinya ueda
Organization Kinki University School of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-2,ohnohigashi,osakasayamashi,osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kinki University School of Medicine
Division name Department of Medical Oncology
Zip code
Address
TEL 0723660221
Homepage URL
Email

Sponsor
Institute Kinki University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2010 Year 08 Month 06 Day

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 Enrolling by invitation
Date of protocol fixation
2010 Year 07 Month 02 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
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
2010 Year 08 Month 06 Day
Last modified on
2010 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004818

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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