UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045147 |
|---|---|
| Receipt number | R000051438 |
| Scientific Title | Prognostic effects of the differences in histopathological evaluation between preoperative chemotherapy with Docetaxel, CDDP and 5-FU and preoperative chemoradiotherapy in locally advanced esophageal squamous cell carcinoma of Stage III or higher : a retrospective study in a single institution |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/08/13 05:01:19 |
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Basic information
Public title
Prognostic effects of the differences in histopathological evaluation between preoperative chemotherapy and preoperative chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma
Acronym
Pathological evaluation and remote results of preoperative chemotherapy versus chemoradiotherapy in advanced esophageal cancer
Scientific Title
Prognostic effects of the differences in histopathological evaluation between preoperative chemotherapy with Docetaxel, CDDP and 5-FU and preoperative chemoradiotherapy in locally advanced esophageal squamous cell carcinoma of Stage III or higher : a retrospective study in a single institution
Scientific Title:Acronym
Histopathological evaluation and treatment results of preoperative DCF and preoperative CRT for advanced esophageal cancer
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The retrospective analyses were performed for two different cohorts of preoperative DCF and preoperative CRT in locally advanced esophageal cancer, and in particular, the results of histopathological effect evaluation from surgical specimens were analyzed for the two cohorts. By doing so, we will consider the ideal form of neoadjuvant therapy, the positioning of surgery, and even better surgical methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To systematically examine the difference in histopathological evaluation between preoperative DCF and preoperative CRT and in the remote results of the cohorts
Key secondary outcomes
To clarify the central role of surgery in the multidisciplinary treatment by presenting the remote results of surgery alone performed without overlapping the patient registration period of preoperative chemotherapy and preoperative CRT cohorts.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 30 | years-old | <= |
Age-upper limit
| 82 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients with esophageal squamous cell carcinoma in the pretreatment pathological diagnosis.
2.Patients without simultaneous advanced another cancer.
3.Patients It is resistant to surgery in terms of general condition, cardiopulmonary function, and hepato-renal function.
4.Patients to be the candidates of chemotherapy / chemoradiotherapy
5.Patients with UICC7th cT3 or deeper but borderline excision ability , or cT3N1-3.
6.Patients undergoing radical surgery
Key exclusion criteria
1. No pretreatment pathological diagnosis.
2. Simultaneous advanced another cancer.
3. Anxiety about surgical tolerance before treatment.
4. Chemotherapy cannot be performed due to organ function.
5. Although registered in each cohort before the start of preoperative treatment cases in which the actual surgery was not performed due to reasons including side effects of preoperative treatment, tumor regrowth during preoperative treatment and refusal of the patient.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Hosokawa |
Organization
Keiyukai Sapporo Hospital
Division name
Department of Radiation Oncology
Zip code
0030026
Address
Minami 1-1, Hondori-9, Shiroishi-ku, Sapporo
TEL
+8111-863-2101
miyako98kazm@gmail.com
Public contact
Name of contact person
| 1st name | Miyako |
| Middle name | |
| Last name | Myojin |
Organization
Keiyukai Sapporo Hospital
Division name
Department of Radiation Oncology
Zip code
003-0026
Address
Minami 1-1, Hondori-9, Shiroishi-ku, Sapporo
TEL
+81-11-863-2101
Homepage URL
miyako98kazm@gmail.com
Sponsor or person
Institute
others
Keiyukai Sapporo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Keiyukaisapporo hospital ethics commitee
Address
Minami 1-1, Hondori-9, Shiroishi-ku, Sapporo
Tel
+81-11-863-2101
miyako@keiyukaisapporo.or.jp
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
| 2021 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
132
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
| 2011 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 18 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 19 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 15 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 15 | Day |
Other
Other related information
Observation study about relationship between histopathological evaluation of neoadjuvant therapy and surgical procedures and long-term survival.
Management information
Registered date
| 2021 | Year | 08 | Month | 13 | Day |
Last modified on
| 2021 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051438
