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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000246 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | unresectable, locally recurrent or remnant gastric cancer | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 6 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Date trial data considered complete |
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Other | |
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Management information | |||||||
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Last modified on |
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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 |