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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002029
Receipt No. R000002465
Scientific Title A phase II trial of definitive chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) for advanced esophageal carcinoma (KDOG 0501 P2)
Date of disclosure of the study information 2009/06/01
Last modified on 2014/12/01

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Basic information
Public title A phase II trial of definitive chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) for advanced esophageal carcinoma (KDOG 0501 P2)
Acronym A phase II trial of definitive chemoradiotherapy (DCF-R) for advanced esophageal carcinoma (KDOG 0501 P2)
Scientific Title A phase II trial of definitive chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) for advanced esophageal carcinoma (KDOG 0501 P2)
Scientific Title:Acronym A phase II trial of definitive chemoradiotherapy (DCF-R) for advanced esophageal carcinoma (KDOG 0501 P2)
Region
Japan

Condition
Condition locally advanced esophageal carcinoma
Classification by specialty
Gastroenterology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical effectiveness of chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil for locally advanced esophageal carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes complete response rate
Key secondary outcomes Response rate
Adverse events
Progression free survival(PFS)
Overall Survival(OS)


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 Patients receive an infusion of docetaxel (35 mg/m2) and an infusion of cisplatin (40 mg/m2) on days 1, 15, and 29 plus a continuous infusion of 5-fluorouracil (400 mg/m2/day) on days 1-5, 15-19, and 29-33. And patients receive 50.4 Gy/28 fractions of concurrent radiotherapy.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Histologically confirmed squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, basaloid carcinoma of esophagus.
2. Primary tumor localizes the thoracic esophagus by esophagography.
3. clinically confirmed T4 tumor and/or M1 LYM according to the Tumor-Node-Metastasis classification of the UICC. All areas of nodal disease had to be able to be contained in the radiation field.
4. No other distant metastasis, pleural effusion, ascites, and esophagotracheal or esophagobronchial fistulas.
5. Patients of age =>20 and 75=> at the registration.
6. Patients have never received surgical resection (excepting for endoscopic resection), radiation, or chemotherapy for esophageal cancer.
7. Sufficient organ functions within one week before registration.
1) leukocyte >=3,000/mm3
2) platelets >=100,000/mm3
3) hemoglobin >=10.0g/dl
4) total bilirubin <=1.5mg/dl
5) AST(GOT)/ALT(GPT): within 2 times the upper limit of normal
6) serum creatinine: within the upper limit of normal
7) creatinine clearance >=50ml/min
8) normal ECG
8. Performance Status:0-2(ECOG)
9. Written informed consent.
Key exclusion criteria 1. History of serious drug hypersensitivity
2. Active gastrointestinal bleeding
3. Active infection
4. Severe complication (interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, heart failure, renal failure, liver cirrhosis or etc)
5. Active synchronous or metachronous malignancy other than carcinoma in situ.
6. Mental disorders being treated with antipsychotic agents or requiring treatment
7. Pregnant or lactation women, or women with the possibility of the pregnancy
8. Men who want let to pregnancy
9. Patients who are judged inappropriate for the entry into the study by the investigater
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wasaburo Koizumi
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 2-1-1, Asamizodai, Sagamihara, Kanagawa, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Kitasato University School of Medicine, Department of Gastroenterology
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
2009 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 03 Month 16 Day
Date of IRB
Anticipated trial start date
2005 Year 03 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 01 Day
Last modified on
2014 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002465

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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