UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002093 |
|---|---|
| Receipt number | 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 12:44:35 |
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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
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
taeguchi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002542
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
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