UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008086 |
|---|---|
| Receipt number | R000009370 |
| Scientific Title | Chemoselection as a strategy for organ preservation in clinical stage II/III ESCC: a phase II study of induction chemotherapy with docetaxel, cisplatin and 5-FU (DCF) followed by chemoradiotherapy. |
| Date of disclosure of the study information | 2012/06/02 |
| Last modified on | 2012/06/02 15:25:43 |
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Basic information
Public title
Chemoselection as a strategy for organ preservation in clinical stage II/III ESCC: a phase II study of induction chemotherapy with docetaxel, cisplatin and 5-FU (DCF) followed by chemoradiotherapy.
Acronym
Phase II study to evaluate DCF chemoselection for ESCC
Scientific Title
Chemoselection as a strategy for organ preservation in clinical stage II/III ESCC: a phase II study of induction chemotherapy with docetaxel, cisplatin and 5-FU (DCF) followed by chemoradiotherapy.
Scientific Title:Acronym
Phase II study to evaluate DCF chemoselection for ESCC
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluated the efficacy and safety of chemoradiotherapy for responders with DCF therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival (PFS) at 1 year in patients who were treated with chemoradiotherapy
Key secondary outcomes
1) In all patients, Overall survival (OS) at 1 year and 3 years, PFS at 1 year and 3 years, Esophagectomy free survival.
2) In patients who were treated with chemoradiotherapy, OS at 1 year and 3 years, PFS at 3 year, Complete response rate, Treatment completion rate, Adverse events(AEs).
3) In surgical patients, OS at 1 year and 3 years, PFS at 1 year and 3 years,
Curative resection rate, AEs.
4) Response rate of DCF therapy, AEs.
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
DCF therapy after 2 course followed by tumor assessment.
<Remarkable response>
+ DCF therapy 1 course
+ Chemoradiotherapy 2 course
+- Salvage surgery
<Limited partial response>
+ DCF therapy 1 course
+ Surgery
<Poor response>
+ Surgery
[DCF therapy]
Docetaxel 75 mg/m2 day1
Cisplatin 75 mg/m2 day1
Fluorouracil 750 mg/m2 day1-5
Every 3 weeks
[Chemoradiotherapy]
Fluorouracil 750 mg/m2 day1-4
Cisplatin 75 mg/m2 day1
Every 4 weeks
RT 50.4Gy
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) Diagnosed squamous cell carcinoma by endoscopic biopsy.
2) Confirmed the lesion of thoracic esophagus (An accessory lesion of EMR absolute criteria may not be localized thoracic esophagus).
3) Clinical stage II/III without T4 in TNM classification (UICC 6th).
4) Age more than 20years and less than 75 years.
5) PS(ECOG) of 0 or 1.
6) No previous treatment expect endoscopic resection of esophageal cancer.
7) No previous chemotherapy or radiation therapy for other malignancy.
8) No severe organ failure.
9) Possibility of transthoracic and/or transabdominal curative resection of esophageal cancer.
10) Signed informed consent of the patient for the registration.
Key exclusion criteria
1) An active malignancy other than carcinoma in situ or mucosal carcinoma or a history of other malignancy within the past 5 years.
2) Women who are pregnant, lactating, or wish to become pregnant.
3) Unsuitable mental status and condition for clinical trials.
4) Received continuous steroids (orally or intravenous) administration.
5) Positive HBs antigen.
6) Unstable diabetes mellitus with oral hypoglycemic agent or insulin.
7) Acute myocardial infarction within the past 3 months.
8) Severe complications (COPD, interstitial lung disease, pulmonary fibrosis, heart failure and so on) .
9) Active bacterial or fungous infection(body temperature more than 38.5 degrees and proved bacterial infection by diagnostic imaging or bacteriological examination ) .
10) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Tahara |
Organization
National Cancer Center Hospital East
Division name
Division of Head and neck Medical Oncology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL
04-7133-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chikatoshi Katada |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-15-1 Kitasato, Sagamihara, Kanagawa, 252-0374, Japan
TEL
042-778-8111
Homepage URL
ckatada@med.kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Medical research support company with limited liability
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
北里大学、国立がん研究センター東病院、富山大学、聖マリアンナ医科大学病院、慶応義塾大学病院、埼玉県立がんセンター、自治医科大学附属病院、佐久総合病院、京都大学
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 02 | Day |
Last modified on
| 2012 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009370
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