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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000278
Receipt No. R000000353
Scientific Title Neoadjuvant chemotherapy using the TXL and CDDP followed by surgery for advanced gastric cancer - Phase II
Date of disclosure of the study information 2005/11/09
Last modified on 2009/12/21

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Basic information
Public title Neoadjuvant chemotherapy using the TXL and CDDP followed by surgery for advanced gastric cancer - Phase II
Acronym TC-NAC-P2
Scientific Title Neoadjuvant chemotherapy using the TXL and CDDP followed by surgery for advanced gastric cancer - Phase II
Scientific Title:Acronym TC-NAC-P2
Region
Japan

Condition
Condition advanced gastric cancer
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this trial is to evaluate the efficacy and safety of neoadjuvant chemotherapy using paclitaxel and cisplatin regimen for advanced gastric cancer, which is not able to be completely resected without neoadjuvant chemotherapy or has an extremely poor prognosis if we could resect.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pathorogical response rate for all eligibility population
Key secondary outcomes three year survival rate, pathorogical response rate for patients who completed the protocol treatment, the proportion of complete resection, the proportion of patients who completed the protocol treatment, response rate of neoadjuvant chemotherapy, adverse event

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 Maneuver
Interventions/Control_1 This nepadjuvant chemotherapy (NAC) regimen is as follows: 80mg/m2 TXL and 25mg/m2 CDDP is administered on days 1, 8, 15 with a 1-week rest, and is totally administered between 2 and 4 courses. After NAC, patients undergo surgery. If patients have a pathological response or cytological response, they are submitted to the same postoperative chemotherapy regimen for totally 4 courses with NAC.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven gastric carcinoma
2) Upper gastrointestinal endoscopy, examinations, or CT revealed the following criteria: i)cStage IIIb-IV and H0 and M0 and P0, ii) Esophageal invasion and cStage IIIa, iii) scirrhous gastric cancer (type3 or type4) and cStage IIIa
3) Thoracic/ abdominal/ pelvic enhanced CT revealed none of the following: mediastinal lymph node metastais, cervical lymph node metastasis, lung metastasis, peritoneal metastasis, liver metastasis, pleural effusion, ascites beyond the pelvis, and other distant metastasis
4) Clinically no sign of distant metastasis
5) No peritoneal metastasis and CY0 by laparoscopy
6) Age between 20 and 80 at registration
7) Performance Status(ECOG) 0 or 1
8) No prior chemotherapy or radiotherapy
9) No prior surgery for gastric carcinoma except for bypass surgery and endoscopic mucosal resection
10) Fair oral intake with or without bypass surgery
13) Blood test
i) WBC >= 4,000/mm3, Neu >= 2,000/mm3 and WBC <= 12,000/mm3
ii) Hb >= 8.0 g/dl
iii) Platelet >= 100,000/mm3
iv) GOT <= 100IU
v) GPT <= 100IU
vi) T.bil <= 2.0 mg/dl
vii) Creatinin <= 1.5mg/dl
viii) ECG: normal
11) Written informed consent
Key exclusion criteria 1) Serious complications
2) Active multiple cancer
3) Obvious infection or acute inflammatory condition
4) Under treatment with systemic steroid
5) Probable pregnancy, and the period of lactation
6) Difficulty to join the trial due to psychosis or psychotic symptoms
7) Allergy to drugs containing Cremophor EL (including cyclosporin)
8) History of severe drug allergic reaction
9) History of alcoholic allergic reaction
10) Peripheral neuropathy
11) Not fit to the protocol treatment by the physicion's dicision
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Nagata
Organization University of Occupational & Environment Health
Division name Department of Surgery I
Zip code
Address 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu-shi, 807-8555, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Fukushima
Organization Kyoto University
Division name Epidemiological & Clinical Research Information Management
Zip code
Address
TEL 075-752-1519
Homepage URL
Email

Sponsor
Institute TC therapy for gastric cancer study group
Institute
Department

Funding Source
Organization Epidemiological & Clinical Research Information Management
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
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
2005 Year 11 Month 09 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 Completed
Date of protocol fixation
2005 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date
2005 Year 10 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 11 Month 08 Day
Last modified on
2009 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000353

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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