UMIN-CTR Clinical Trial

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
Email

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
Email	m2kimura@marianna-u.ac.jp

Sponsor
Institute	Multi-modality therapy for gastric cancer study group
Institute
Department

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000309

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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