UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034373 |
|---|---|
| Receipt number | R000039186 |
| Scientific Title | A phase II, multicenter study to investigate the safety and efficacy of atezolizumab monotherapy as a sequential therapy following chemoradiotherapy in patients with locally advanced unresectable esophageal cancer |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2023/06/16 07:11:44 |
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Basic information
Public title
A phase II, multicenter study to investigate the safety and efficacy of atezolizumab monotherapy as a sequential therapy following chemoradiotherapy in patients with locally advanced unresectable esophageal cancer
Acronym
TENERGY Study
Scientific Title
A phase II, multicenter study to investigate the safety and efficacy of atezolizumab monotherapy as a sequential therapy following chemoradiotherapy in patients with locally advanced unresectable esophageal cancer
Scientific Title:Acronym
TENERGY Study
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the clinical efficacy and safety of atezolizumab monotherapy, following definitive chemoradiotherapy with fluorouracil and cisplatin in patients with unresectable locally advanced esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Confirmed complete response rate by investigators' assessment
Key secondary outcomes
- Confirmed complete response rate by central assessment
- Progression-free survival
- Objective Response rate
- Overall survival
- Incidences of adverse events
- Sites of progressive disease
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
Monotherapy with Atezolizumab (1200 mg), every 3 weeks intravenous administration
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
Eligibility criteria of primary part;
1. Histologically confirmed esophagus squamous cancer, adenosquamous cell carcinoma or basaloid-squamous carcinoma.
2. The primary lesion located within the thoracic esophagus
3. Diagnosed unresectable cancer with computed tomography (CT) scanned before the chemoradiotherapy (CRT)
4. No distant metastasis except supraclavicular lymph node with the CT before the CRT
5. No prior treatment for the esophageal cancer except endoscopic resection before CRT
6. Able to be enrolled to the study within 28 days after CRT that fulfills the requirements
7.
Eligibility criteria of postoperative recurrence part:
1. Surgical specimen histologically diagnosed as esophagus squamous cancer, adenosquamous cell carcinoma or basaloid-squamous carcinoma.
2. Unresectable, locoregionally recurrent cancer that can be treated with definitive CRT after the curative surgery for the primary esophageal cancer
3. No distant metastasis except supraclavicular lymph node with the CT before CRT
4. 24 weeks or longer elapsed on the first day of CRT after adjuvant chemotherapy, if conducted
5. Able to be enrolled to the study within 28 days after CRT that fulfills the requirements
6.
Common eligibility criteria
1. Age of 20 years or older
2. ECOG performance status of 0 or 1
3. Adequate hematologic and organ function
4. For women of childbearing potential: negative in a urine pregnancy test
5. Agreement to use an effective form of contraceptive methods from the consent through five months after the last dose of atezolizumab
6. Life expectancy of 3 months or longer
7. Singed informed consent form
Key exclusion criteria
1. Active double cancers
2. Requiring systemic treatment for active infection
3. Past or concurrent inflammatory bowel disease
4. Past or concurrent interstitial lung disease
5. Concurrent autoimmune disease or past chronic or recurrent autoimmune disease
6. Requiring Systemic treatment with corticosteroids or immunosuppressants or who have received these treatments within 14 days before the enrollment in the study
7. Past or concurrent thyroid dysfunction
8. A history or finding of cardiovascular risk
9. Poorly controlled diabetes mellitus.
10. Positive for any of the followings: HIV antibody, HBs antigen, HCV antibody test.
11. Pregnant or lactating
12. Clinically significant unstable psychiatric disorders or other medical disorders
13. No prior treatment with atezolizumab, anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody or anti-CTLA-4 antibody, or any other antibody or drug therapy regulating T cell
14. Not willing to comply or incapable of complying with the procedures specified in the protocol.
15. Unsuitable for the study due to such as a complicated disorder affecting the assessment of toxicity in the investigator's judgment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kojima |
Organization
National Cancer Center Hospital East
Division name
Gastrointestinal Oncology Division
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
tenergy_core@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Bando |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan
TEL
052-762-6111
Homepage URL
tenergy_core@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Hospital East
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital Institutional Review Board
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
Tel
04-7133-1111
irboffice@east.ncc.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
国立研究開発法人国立がん研究センター東病院（千葉県）
国立研究開発法人国立がん研究センター中央病院（東京都）
埼玉県立がんセンター（埼玉県）
がん研究会有明病院（東京都）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | 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
| 2018 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 05 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039186
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