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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031165
Receipt No. R000035272
Scientific Title A phase III study of tri-modality combination therapy with induction docetaxel plus cisplatin and 5-fluorouracil (DCF) vs definitive chemoradiotherapy for locally advanced unresectable squamous cell carcinoma of the thoracic esophagus(JCOG1510,TRIANgLE)
Date of disclosure of the study information 2018/02/06
Last modified on 2018/02/06

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Basic information
Public title A phase III study of tri-modality combination therapy with induction docetaxel plus cisplatin and 5-fluorouracil (DCF) vs definitive chemoradiotherapy for locally advanced unresectable squamous cell carcinoma of the thoracic esophagus(JCOG1510,TRIANgLE)
Acronym A phase III study of tri-modality combination therapy with induction docetaxel plus cisplatin and 5-fluorouracil (DCF) vs definitive chemoradiotherapy for locally advanced unresectable squamous cell carcinoma of the thoracic esophagus(JCOG1510,TRIANgLE)
Scientific Title A phase III study of tri-modality combination therapy with induction docetaxel plus cisplatin and 5-fluorouracil (DCF) vs definitive chemoradiotherapy for locally advanced unresectable squamous cell carcinoma of the thoracic esophagus(JCOG1510,TRIANgLE)
Scientific Title:Acronym A phase III study of tri-modality combination therapy with induction docetaxel plus cisplatin and 5-fluorouracil (DCF) vs definitive chemoradiotherapy for locally advanced unresectable squamous cell carcinoma of the thoracic esophagus(JCOG1510,TRIANgLE)
Region
Japan

Condition
Condition locally advanced unresectable squamous cell carcinoma of the thoracic esophagus
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this randomised phase III study is to confirm the superiority of triplet combination chemotherapy that consists of 5-FU, cisplatin, and docetaxel (DCF) followed by radical surgery or definitive chemoradiotherapy comparing with standard definitive chemoradiotherapy for patients with locally advanced unresectable squamous cell carcinoma of the thoratic esophagus in overall survival
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes overall survival
Key secondary outcomes progression free survival, complete response proportion of chemoradiotherapy, response proportion of DCF (in case of Arm B), adverse events of DCF and chemoradiotherapy, late onset adverse events, perioperative complications (both Arm A and Arm B)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 A: two courses of chemotherapy with cisplatin (70 mg/m2, 2-h intravenous infusion on day 1) and 5-FU (700 mg/m2, 24-h continuous intravenous infusion on days 1-4) repeated every 4 weeks in combination with radiotherapy (a total dose of 60 Gy in a fraction of 2 Gy five times weekly) followed by two courses of additional chemotherapy with cisplatin (80 mg/m2, 2-h intravenous infusion on day 1), and 5-FU (800mg /m2, 24-h continuous intravenous infusion on days 1-5) repeated every 4 weeks. Salvage treatment can be performed in accordance with the assessment after chemoradiotherapy.
Interventions/Control_2 B: three courses of induction chemotherapy with docetaxel (70 mg/m2, 1-h intravenous infusion on day 1), cisplatin (70 mg/m2, 2-h intravenous infusion on day 1), and 5-FU (750 mg/m2, 24-h continuous intravenous infusion on days 1-5) repeated every 3 weeks, followed by conversion surgery or two courses of chemotherapy with cisplatin (70 mg/m2, 2-h intravenous infusion on day 1) and 5-FU (700 mg/m2, 24-h continuous intravenous infusion on days 1-4) repeated every 4 weeks in combination with radiotherapy (a total dose of 60 Gy in a fraction of 2 Gy five times weekly) based on the clinical evaluation. Salvage treatment can be performed in accordance with the assessment after chemoradiotherapy.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma or basaloid cell carcinoma. Biopsy of accessory lesions is not mandatory.
2) Primary tumor located in thoracic esophagus (the UICC 7th edition). Tumor invading cervical or abdominal esophagus with indication of definitive radiation therapy and accessory lesions with indication of EMR are eligible.
3) Unresectable esophageal cancer based on cervical to abdominal contrast enhanced CT to fulfill either following A) or B), and patients with both unresectable supraclavicular lymph nodes and celiac artery lymph nodes metastases are ineligible.
A) cT4b or cT3 that may invade adjacent organs in accordance with UICC-TNM 7th edition and Japanese Classification of Esophageal Cancer 11th edition.
B) Other adjacent organs except esophagus are or may be invaded by regional lymph nodes or supraclavicular lymph nodes metastases.
4) No distant metastases except supraclavicular lymph nodes metastases in accordance with cervical to abdominal contrast enhanced CT. Pelvic CT is not mandatory.
5) Diagnosed by radio oncologists before register as a candidate of definitive radiotherapy in 60 Gy within the dose constraints of other organs. CT for treatment planning before register is not mandatory.
6) Aged 20 to 75 years old.
7) ECOG Performance status 0 or 1.
8) Measurable lesions not required.
9) No prior treatment for esophageal cancer except endoscopic resection.
10) No prior chemotherapy and radiotherapy for any cancer.
11) Sufficient organ functions; fulfilling all of the following conditions within 14 days;
i. Neutrophil >= 2,000/mm3
ii. Platelet >= 100,000/mm3
iii. Hb >= 9.0 g/dL
iv. T.Bil <= 1.5 mg/dL
v. AST <= 100 IU/L
vi. ALT <= 100 IU/L
vii. CCr >= 60mL/min (Cockcroft-Gault)
viii. SpO2 (room air) >=95%
12) Agreement with surgical procedure as protocol tratment if R0 esophagectomy is judged as possible.
13) Written informed consent.
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers.
2) Prior surgery for head and neck superficial carcinoma within 5 years.
3) Diagnosed with active infectious disease requiring systemic treatment by imaging or bacteriological inspections, and body temperature >= 38 degrees Celsius.
4) Positive for HBs antigen or HIV antigen.
5) Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding. Male subjects who want pregnancy of their partner.
6) Psychological disorder difficult to participate in this clinical study.
7) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
8) Under treatment by flucytosine, phenytoin, or warfarin potassium .
9) Previous histry of allergy to iodine.
10) Diabetes mellitus uncontrollable with continuous use of insuline or hypoglycemic agents.
11) Severe emphysema or pulmonary fibrosis based on chest CT.
12) Uncontrolled arterial hypertension.
13) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
14) Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
Target sample size 230

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Daiko
Organization National Cancer Center Hospital
Division name surgery division
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
TEL 03-3542-2511
Email hdaiko@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Hara
Organization JCOG1510 Coordinating Office
Division name Saitama Cancer Center Department of Gastroenterology
Zip code
Address 780, Komuro, Ina-machi, Kitaadachi-gun, Saitama, 362-0806, Japan
TEL 048-722-1111
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 北海道大学病院(北海道)
岩手医科大学(岩手県)
東北大学病院(宮城県)
茨城県立中央病院・茨城県地域がんセンター(茨城県)
栃木県立がんセンター(栃木県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学国際医療センター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
千葉大学医学部(千葉県)
東京歯科大学市川総合病院(千葉県)
国立がん研究センター中央病院(東京都)
東京女子医科大学(東京都)
国立病院機構東京医療センター(東京都)
慶應義塾大学病院(東京都)
昭和大学病院(東京都)
がん研究会有明病院(東京都)
虎の門病院(東京都)
東海大学医学部(神奈川県)
神奈川県立がんセンター(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
新潟大学医歯学総合病院(新潟県)
静岡県立総合病院(静岡県)
浜松医科大学(静岡県)
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)
名古屋大学医学部(愛知県)
京都大学医学部附属病院(京都府)
大阪国際がんセンター(大阪府)
国立病院機構大阪医療センター(大阪府)
大阪急性期・総合医療センター(大阪府)
大阪市立総合医療センター(大阪府)
大阪医科大学(大阪府)
神戸大学医学部(兵庫県)
関西労災病院(兵庫県)
兵庫県立がんセンター(兵庫県)
岡山大学病院(岡山県)
広島大学病院(広島県)
広島市立安佐市民病院(広島県)
国立病院機構四国がんセンター(愛媛県)
高知医療センター(高知県)
国立病院機構九州がんセンター(福岡県)
九州大学病院(福岡県)
佐賀大学医学部(佐賀県)
熊本大学医学部(熊本県)
大分大学医学部附属病院(大分県)
鹿児島大学病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2018 Year 02 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 Open public recruiting
Date of protocol fixation
2017 Year 11 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 06 Day
Last follow-up date
2026 Year 08 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 06 Day
Last modified on
2018 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035272

Research Plan
Registered date File name

Research case data specifications
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Research case data
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