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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034373
Receipt No. 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 2019/01/07

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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

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

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
Middle name
Last name Takashi Kojima
Organization National Cancer Center Hospital East
Division name Gastrointestinal Oncology Division
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 04-7133-1111
Email tenergy_core@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Bando
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan
TEL 052-762-6111
Homepage URL
Email tenergy_core@east.ncc.go.jp

Sponsor
Institute National Cancer Center
Hospital East
Institute
Department

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
Address
Tel
Email

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中央病院(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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 04 Day
Last modified on
2019 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039186

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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