UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000246 |
|---|---|
| Receipt number | R000000309 |
| Scientific Title | Paclitaxel plus cisplatin and concurrent radiation for unresectable, locally recurrent or remnant gastric cancer in the left upper abdomen – phase I study |
| Date of disclosure of the study information | 2005/09/22 |
| Last modified on | 2007/07/23 10:24:38 |
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Basic information
Public title
Paclitaxel plus cisplatin and concurrent radiation for unresectable, locally recurrent or remnant gastric cancer in the left upper abdomen – phase I study
Acronym
Paclitaxel plus cisplatin and concurrent radiation for unresectable, locally recurrent or remnant gastric cancer – phase I study(MMTG study)
Scientific Title
Paclitaxel plus cisplatin and concurrent radiation for unresectable, locally recurrent or remnant gastric cancer in the left upper abdomen – phase I study
Scientific Title:Acronym
Paclitaxel plus cisplatin and concurrent radiation for unresectable, locally recurrent or remnant gastric cancer – phase I study(MMTG study)
Region
| Japan |
Condition
Condition
unresectable, locally recurrent or remnant gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this phase I study is to determine the dose-limiting toxicities, maximum-tolerated dose and recommended dose of biweekly paclitaxel plus cisplatin and concurrent radiation for unresectable, locally recurrent or remnant gastric cancer in the left upper abdomen. The efficacy is evaluated by the improved rates of bowel stenosis and pain relief.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Recommended dose
Key secondary outcomes
1) Dose-limiting toxicities
2) Maximum-tolerated dose
3) The improved rate of bowel stenosis
4) The improved rate of pain relief
5) Overall survival
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
Treatments consisted of chemotherapy of biweekly paclitaxel plus cisplatin and concurrent radiation for 5 weeks for unresectable, locally recurrent or remnant gastric cancer.
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) Patients underwent gastrectomy for histologically proven adenocarcinoma of the stomach
2) Unresectable, locally recurrent or remnant gastric cancer of left upper abdomen with invasion to the small intestine or local pain
3) Eastern Clinical Oncology Group (ECOG) performance status of 0-1
4) Prior chemotherapy within 1 regimen except adjuvant chemotherapy or neo-adjuvant chemotherapy
5) No prior chemotherapy of paclitaxel plus cisplatin, or no administration of cisplatin >= 240mg/m2
6) Prior chemotherapy completed 3 weeks before entry
7) No prior radiation therapy to the local area
8) Life expectancy more than 2 months
9) Adequate bone marrow function; white blood cell [WBC] count between 4000/ml and 10000/ml
neutrophil count >=2000/ml
platelet count >=100000/ml
hemoglobin >= 8.0 g/dl
GOT and GPT < 100U/l
serum bilirubin level < 2.0 mg/dl
serum creatinine level < 1.5 mg/dl
normal electrocardiogram (ECG)
10) No other active malignancy
11) Written informed consent
Key exclusion criteria
1) Local tumor is not identified by computerized tomography (CT), endoscope or gastrointestinal examination
2) Other severe medical conditions
3) Patients need treatments for bowel obstruction or bleeding
4) Obvious infection or acute inflammatory condition
5) Allergy to drugs containing Cremophor EL (including cyclosporin)
6) Brain metastases with clinical symptom
7) Women who is pregnant, lactating or have the possibility of pregnancy
8) Patients who is judged inappropriate by lead principal investigator
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaki Yoshikawa |
Organization
Kanagawa Cancer Center
Division name
The Department of Gastrointestinal Surgery
Zip code
Address
1-1-2 Nakao, Asahi-ku, Yokohama-shi, 241-0815, Japan
TEL
045-391-5761
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Kimura |
Organization
St.Marianna University School of Medicine Hospital
Division name
The Department of Gastrointestinal Surgery
Zip code
Address
22-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan.
TEL
044-977-8111
Homepage URL
m2kimura@marianna-u.ac.jp
Sponsor or person
Institute
Multi-modality therapy for gastric cancer study group
Institute
Department
Personal name
Funding Source
Organization
Non-Profit Organization ECRIN (Epidemiological and Clinical Research Information Network)
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 | 09 | Month | 22 | 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 | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 21 | Day |
Last modified on
| 2007 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000309
