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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002093
Receipt No. R000002542
Scientific Title Feasibility study of 5-fluorouracil, leucovorin and paclitaxel (FLTAX) in peritoneal disseminated gastric cancer with massive ascites or inadequate oral intake
Date of disclosure of the study information 2009/06/20
Last modified on 2012/08/31

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Basic information
Public title Feasibility study of 5-fluorouracil, leucovorin and paclitaxel (FLTAX) in peritoneal disseminated gastric cancer with massive ascites or inadequate oral intake
Acronym Feasibility study of FLTAX in gastric cancer with severe peritoneal metastasis
Scientific Title Feasibility study of 5-fluorouracil, leucovorin and paclitaxel (FLTAX) in peritoneal disseminated gastric cancer with massive ascites or inadequate oral intake
Scientific Title:Acronym Feasibility study of FLTAX in gastric cancer with severe peritoneal metastasis
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Part I: to evaluate maximum tolerated dose and dose limiting toxicities to determine recommended dose of 5-fluorouracil, leucovorin and paclitaxel in patients with severe peritoneal disseminated gastric cancer.
Part II: to evaluate the safety of combination chemotherapy with 5-fluorouracil, leucovorin and paclitaxel in patients with severe peritoneal disseminated gastric cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Part I: Incidence of dose limiting toxicity
Part II: Proportion of patients who completed 2 cycles of the protocol treatment
Key secondary outcomes Adverse events, Response rate, Response for ascites, Overall survival, Progression-free survival, Time to treatment failure

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 5-FU 500-600mg/m2 days 1, 8, 15
l-Leucovorin 250mg/m2, days 1, 8, 15
Paclitaxel 60-80mg/m2, days 1, 8, 15
Every 28 days
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. Unresectable or recurrent gastric cancer
2. Histologically confirmed adenocarcinoma
3. Peritoneal metastasis with massive ascites or inadequate oral intake
4. with or without measurable lesion
5. Age 20-80 years
6. PS 0-2
7. First line chemotherapy or prior chemotherapy went as follows: a) recurrence within 6 months after, or during adjuvant chemotherapy, b) progression after continuous infusion of 5-fluorouracil and c) progression after oral fluoropyrimidine-based chemotherapy
8. No previous chemotherapy or radiotherapy for other than gastric cancer
9. Preserved organ functions
10. Written informed consent
Key exclusion criteria 1. Uncontrollable diabetes mellitus
2. Uncontrollable heart disease
3. Other severe complications such as renal failure, liver failure and intestinal pneumonitis
4. Symptomatic CNS metastasis
5. History of hypersensitivity to alcohol
6. Prior taxane-containing chemotherapy
7. Active bacterial or fungous infection
8. Massive pleural effusion
9. Severe diarrhea
10. Active bleeding
11. Active double cancer
12. Pregnancy, the desire to preserve fecundity, or lactating woman
13. Severe mental disorder
14. Patient evaluated to be inadequate by a attending doctor
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takako Eguchi Nakajima
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takako Eguchi Nakajima
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Homepage URL
Email taeguchi@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization none
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
2009 Year 06 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://jjco.oxfordjournals.org/content/42/9/787.long
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
2009 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2011 Year 07 Month 01 Day
Date of closure to data entry
2011 Year 08 Month 01 Day
Date trial data considered complete
2011 Year 08 Month 01 Day
Date analysis concluded
2011 Year 08 Month 01 Day

Other
Other related information Planned patients were recruited on March 2, 2010.
Protocol was firstly amended for additional 7 patients on February 23, 2010, and then protocol was re-amended for additional 3 patients on May 19, 2010 because of the need for further assesment limiting to first line patients.This 3 patients were enrolled until July 20.

Management information
Registered date
2009 Year 06 Month 19 Day
Last modified on
2012 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002542

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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