UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050229 |
|---|---|
| Receipt number | R000057062 |
| Scientific Title | A prospective observational study on conversion surgery for esophageal cancer with distant metastasis |
| Date of disclosure of the study information | 2023/02/04 |
| Last modified on | 2024/08/06 07:34:19 |
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Basic information
Public title
A prospective observational study on conversion surgery for esophageal cancer with distant metastasis
Acronym
M1 Esophageal Cancer Conversion Surgery Study
Scientific Title
A prospective observational study on conversion surgery for esophageal cancer with distant metastasis
Scientific Title:Acronym
M1 Esophageal Cancer Conversion Surgery Study
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of conversion surgery in untreated unresectable esophageal cancer with distant metastasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival (assessed by 3-year survival rate)
Key secondary outcomes
Treatment content, progression-free survival, response rate, disease control rate, adverse events, safety of conversion surgery (intraoperative and postoperative complications), overall survival in R0 resection patients, progression-free survival, date of recurrence, recurrence form, pathological response
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The primary tumor is located at either the cervical, thoracic esophagus, or esophagogastric junction (UICC-TMN 8th edition).
Histopathologically diagnosed as squamous cell carcinoma, adenosquamous cell carcinoma, basaloid carcinoma, or adenocarcinoma.
Planned treatment (excluding palliative treatment) for untreated esophageal cancer with distant metastasis (distant organ metastasis or distant lymph node metastasis).
he presence of distant metastasis (distant organ metastasis or distant lymph node metastasis) has been confirmed by imaging (CT, MRI or PET) or histopathologically.
Distant metastatic organs shall be liver/lung, bone, brain, etc., regardless of number, size, or distribution. Distant lymph nodes are regional extraneous lymph nodes, excluding supraclavicular and intramediastinal lymph nodes. Duplication of distant metastatic organs and distant lymph nodes is allowed.
Examples of distant metastatic organs of esophageal cancer
Liver, lung, lymph node, bone, brain, adrenal gland, skin, muscle, peritoneum, pleura, pericardium, etc.
Age: 20 years old or older
ALT less tahn 100 IU/L
Creatinine clearance more than 40ml/min (Cockcroft-Gault formula)
Patients with a prognosis of 3 months or longer
Patients who have given their consent to participate in the study
Key exclusion criteria
Active multiple cancers at the start of first treatment
Previous history of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody, or other antibody therapy or drug therapy for the purpose of controlling T cells patients with
History of autoimmune disease, interstitial pneumonia, history of organ transplantation, or tuberculosis
Patients who are expected to undergo esophageal or tracheal stenting
Patients who are judged to lack the ability to consent due to complications such as dementia
Patients who are judged to be inappropriate for this study by the attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keijiro |
| Middle name | |
| Last name | Sugimura |
Organization
KansaiRosai Hospital
Division name
Gastroenteological Surgery
Zip code
660-8511
Address
3-1-69 Inabaso, Amagasaki City, Hyogo Prefecture
TEL
06-6416-1221
sugimura-keijiro@kansaih.johas.go.jp
Public contact
Name of contact person
| 1st name | Keijiro |
| Middle name | |
| Last name | Sugimura |
Organization
Kansai Rosai Hospital
Division name
Gastroenteological Surgery
Zip code
660-8511
Address
3-1-69 Inabaso, Amagasaki City, Hyogo Prefecture
TEL
06-6416-1221
Homepage URL
sugimura-keijiro@kansaih.johas.go.jp
Sponsor or person
Institute
Kansai Rosai 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
Osaka University Gastroenterological Surgery, Osaka International Cancer Center, Kinki University Surgery, Osaka Illness Center Surgery, Osaka Acute Disease Center Surgery, Sakai Municipal Medical Center Surgery, Kindai Nara Hospital Surgery, Kansai Medical University Hospital Surgery
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Rosai Hospital Clinical Trial Office
Address
3-1-69 Inabaso, Amagasaki City, Hyogo Prefecture
Tel
06-6416-1221
chiken@kansaih.johas.go.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
| 2023 | Year | 02 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2031 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2032 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2023 | Year | 02 | Month | 03 | Day |
Last modified on
| 2024 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057062
