UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058642 |
|---|---|
| Receipt number | R000067062 |
| Scientific Title | Nationwide survey on treatment strategies for synchronous coexisting esophageal and head and neck cancers |
| Date of disclosure of the study information | 2025/07/30 |
| Last modified on | 2025/07/30 11:01:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Nationwide survey on treatment strategies for synchronous coexisting esophageal and head and neck cancers
Acronym
Nationwide survey on treatment strategies for synchronous coexisting esophageal and head and neck cancers
Scientific Title
Nationwide survey on treatment strategies for synchronous coexisting esophageal and head and neck cancers
Scientific Title:Acronym
Nationwide survey on treatment strategies for synchronous coexisting esophageal and head and neck cancers
Region
| Japan |
Condition
Condition
esophageal and head and neck cancers
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Oto-rhino-laryngology |
| Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We conducted a retrospective, multicenter collaborative study in Japan on synchronous coexisting esophageal cancer and head and neck cancer to clarify the current treatment strategies and outcomes and to explore optimal treatment methods for further improvement of outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year overall survival rate
Key secondary outcomes
5-year recurrence-free survival rate, treatment-related adverse events (surgery, chemotherapy, radiation therapy), cause of death (esophageal cancer, head and neck cancer, death from other cancers, death from other diseases)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Esophageal cancer: Patients with lesions mainly located in the cervical and thoracic esophagus and gastroesophageal junction. Histological type is not specified.
Head and neck cancer: Patients with lesions mainly located in the larynx and middle and lower pharynx. Histological type is limited to squamous cell carcinoma.
Key exclusion criteria
Head and neck cancer: Patients with lesions mainly located in the lips and oral cavity, nasal cavity and paranasal sinuses, major salivary glands, and nasopharynx. Also, patients with non-squamous cell carcinoma of the larynx and middle and lower pharynx.Cases that refused participation by opting out
Target sample size
752
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Watanabe |
Organization
Division of Esophageal Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Division name
Division of Esophageal Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo, 135-8550, Japan
TEL
0335200111
jun.kanamori@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Kanamori |
Organization
Division of Esophageal Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Rese
Division name
Division of Esophageal Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Rese
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo, 135-8550, Japan
TEL
0335200111
Homepage URL
jun.kanamori@jfcr.or.jp
Sponsor or person
Institute
Division of Esophageal Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Esophageal Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Rese
Address
3-8-31, Ariake, Koto, Tokyo, 135-8550, Japan
Tel
0335200111
jun.kanamori@jfcr.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
| 2025 | Year | 07 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient Information
Age, gender, American Society of Anesthesiologists (ASA) physical status classification, smoking history, alcohol consumption history, location and stage of esophageal cancer and head and neck cancer (TNM classification), history of treatment for other malignant diseases (surgery, radiation therapy, dose, chemotherapy), etc.
Treatment Information
Sequence of primary and secondary treatments, as well as details of each treatment and treatment-related adverse events
Endoscopic Treatment: Treatment date, number of lesions, intraoperative and postoperative complications, necessity of additional treatment, etc.
Surgery: Surgery date, surgical procedure, surgery duration, blood loss, reconstructed organs (stomach, small intestine, colon, etc.), reconstruction route, presence or absence of vascular reconstruction, postoperative complications (Clavien-Dindo classification), presence or absence of reoperation, presence or absence of surgery-related mortality, postoperative hospital stay duration, etc.
Chemotherapy (including immunotherapy): Treatment start date, selected regimen, number of administrations, treatment-related adverse events (Common Terminology Criteria for Adverse Events v4.0 (CTCAE)), etc.
Radiation therapy: Radiation start date, radiation field and dose, presence or absence of concurrent or sequential chemotherapy, treatment-related adverse events (CTCAE), etc.
Prognosis information
5-year survival rate, 5-year disease-free survival, treatment-related mortality rate, cause of death (esophageal cancer, head and neck cancer, death from other cancers, death from other causes), larynx preservation rate, etc.
Management information
Registered date
| 2025 | Year | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067062
