UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000278 |
|---|---|
| Receipt number | 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 21:06:01 |
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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
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
Sponsor or person
Institute
TC therapy for gastric cancer study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000353
