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

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 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


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

Value
https://center6.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