UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043767 |
|---|---|
| Receipt number | R000049943 |
| Scientific Title | Nagoya University Esophageal Cancer CRT+/-PDT Prognostic Study |
| Date of disclosure of the study information | 2021/07/06 |
| Last modified on | 2021/07/02 17:00:43 |
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Basic information
Public title
Prospective Multicenter Observational Study of Esophageal Preservation Survival in definitive Chemoradiotherapy +/- Photodynamic Therapy for Esophageal Cancer
Acronym
Nagoya University Esophageal Cancer CRT+/-PDT Prognostic Study
Scientific Title
Nagoya University Esophageal Cancer CRT+/-PDT Prognostic Study
Scientific Title:Acronym
NEC2P2 Study
Region
| Japan |
Condition
Condition
Esophageal Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to collect cases of stage I-IVa esophageal cancer treated with radical (chemo)radiation therapy and to clarify the esophagus preservation survival rate of salvage PDT for patients with local recurrence after radical (chemo)radiation therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-year esophageal preservation survival, 5-year esophageal preservation survival of I-IVa esophageal cancer radical (chemo)radiation therapy plus salvage PDT
Key secondary outcomes
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with Stage I-IVa esophageal cancer diagnosed by imaging or histological diagnosis, who are inoperable or do not wish to undergo surgery.
2) Patients who are scheduled to undergo dCRT of 50.4 Gy or more.
3) Histologically proven esophageal cancer (any of the common histological types) by endoscopic biopsy of the primary esophageal tumor.
4) Patients must have adequate organ function, and if combination chemotherapy is to be administered, either the regimen described in the Guidelines for the Treatment of Esophageal Cancer or fluorouracil plus levofolinate plus oxaliplatin (FOLFOX) is available and will be administered as first-line therapy.
5) Patients must be at least 20 years old at the time of consent.
6) PS (ECOG) is either 0, 1, or 2.
7) Written consent for participation in the study has been obtained from the patient.
Key exclusion criteria
1) Women who are pregnant, may become pregnant (intentionally), or are breastfeeding. Men who wish their partner to become pregnant.
2) Patients with concomitant psychosis or psychiatric symptoms that would make it difficult to participate in the study.
3) Patients with active bacterial and fungal infections (fever of 38 degrees or higher, and bacterial infection documented by imaging or bacteriological examination. (Local infections that do not affect the systemic condition are excluded.
4) Patients with interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
5) History of myocardial infarction or unstable angina within 6 months of enrollment.
6) Patients with poorly controlled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
7) Other patients who are judged by the physician in charge to be unable to tolerate the treatment prescribed in this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Kakushima |
Organization
Nagoya University
Division name
Gastroenterology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi
TEL
052-744-2172
nk202004@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhito |
| Middle name | |
| Last name | Ito |
Organization
Nagoya University
Division name
Gastroenterology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi
TEL
052-744-2172
Homepage URL
nito@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
Nagoya University Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi
Tel
0527442061
ethics@med.nagoya-u.ac.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 | 07 | Month | 06 | 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
| 2021 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation study
Management information
Registered date
| 2021 | Year | 03 | Month | 28 | Day |
Last modified on
| 2021 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049943
