UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002029 |
|---|---|
| Receipt number | 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 11:40:07 |
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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
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
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002465
