UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028252 |
|---|---|
| Receipt number | R000032332 |
| Scientific Title | Phase II trial of neoadjuvant docetaxel + cisplatin + fluorouracil (DCF) therapy for esophageal cancer |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2022/07/18 17:11:11 |
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Basic information
Public title
Phase II trial of neoadjuvant docetaxel + cisplatin + fluorouracil (DCF) therapy for esophageal cancer
Acronym
Phase II trial of neoadjuvant docetaxel + cisplatin + fluorouracil (DCF) therapy for esophageal cancer
Scientific Title
Phase II trial of neoadjuvant docetaxel + cisplatin + fluorouracil (DCF) therapy for esophageal cancer
Scientific Title:Acronym
Phase II trial of neoadjuvant docetaxel + cisplatin + fluorouracil (DCF) therapy for esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of preoperative docetaxel + cisplatin + fluorouracil (DCF) therapy for esophageal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Histopathological response rate
Key secondary outcomes
Curative resection rate, response rate in preoperative therapy, histopathological complete response rate, rate of adverse events during preoperative therapy, rate of perioperative complications, rate of late complications, rate of serious adverse events, progression-free survival, and 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 |
Interventions/Control_1
Docetaxel 70 mg / m2 day 1
Cisplatin 70 mg / m2 day 1
Fluorouracil 750 mg / m2 / day days 1 - 5
Three courses every 3 weeks above
Followed by esophagectomy + D 2 or more lymph node dissection
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.ECOG PS 0-1
2.Endoscopic biopsy of esophageal primary lesion histologically diagnosed as squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma or basal cell carcinoma.
3. Any of the following based on TNM classification (UICC-TNM 7 th edition)
1) cStage IB
2) cStage II
3) cStage III Infiltration into the trachea at the cervical /cervical chest boundary (T4) is eligible. Excluding other T4. So-called borderline-resectable T4 disease, not clearly diagnosed as T4, is eligible.
4) cStage IV with supraclavicular lymph node metastasis and without other distant metastasis.
4. Adequate organ function.
Key exclusion criteria
1) Clear T4 other than invasion of cervical / cervical gastrointestinal tract esophageal cancer
2) Distant metastasis to other than supraclavicular lymph nodes.
3) Esophagogastric junction lesion of which main lesion is located in the stomach rather than the esophagus.
4) Judged not to be eligible by the researchers
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Maeda |
Organization
Nagoya University Hospital
Division name
Department of Clinical Oncology and Chemotherapy
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
052-741-2111
maeda-o@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Maeda |
Organization
Nagoya University Hospital
Division name
Department of Clinical Oncology and Chemotherapy
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
052-741-2111
Homepage URL
maeda-o@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 08 | Month | 01 | 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
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | 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
| 2017 | Year | 07 | Month | 15 | Day |
Last modified on
| 2022 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032332
