UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Tri-modality strategy with Docetaxel plus five-fluorouracil and cisplatin (DCF) induction chemotherapy for locally advanced esophageal cancer
Title of the study (Brief title)	Tri-modality strategy with DCF induction chemotherapy for locally advanced esophageal cancer (COSMOS)
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of tri-modality strategy with docetaxel plus five-fluorouracil and cisplatin (DCF) induction chemotherapy followed by surgical resection or chemoradiotherapy for locally advanced unresectable esophageal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Progression free survival, Response rate of DCF chemotherapy, R0 resection rate, Complete response rate of chemoradiotherapy, Adverse event during DCF chemotherapy, Treatment related death, Perioperative complications, Post-therapeutic complications

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	Surgical resection is performed if tumor is resectable after 3 courses of induction DCF chemotherapy. If tumor is unresectable, chemoradiotherapy is performed. Tumor is re-assessed during irradiation. Surgical resection is performed if tumor is resectable after completion of 30-40Gy of irradiation. If tumor is still unresectable, chemoradiotherapy with 60Gy irradiation is accomplished. Tumor is re-assessed after chemoradiotherapy. If residual tumor is resectable, surgical resection is performed. [DCF therapy] Docetaxel 70 mg/m2 day1 Cisplatin 70 mg/m2 day1 Fluorouracil 750 mg/m2 day1-5 Every 3 weeks [Chemoradiotherapy] Fluorouracil 700 mg/m2 day1-4 Cisplatin 70 mg/m2 day1 Every 4 weeks RT 60Gy
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma 2) All lesion located in the thoracic esophagus 3) Tumor was considered to be unresectable by CT scan or palpation for the following reasons: i) The primary tumor depth was determined to be clinical T4b on the 7th UICC-TNM classification, or regional lymph nodes are suspicious of invasion into adjacent structures However, the cases with esophageal perforation, fistula, bleeding, or stenosis of airway are excluded ii) Nonregional lymph node metastasis with immovable supraclavicular nodes. However, the cases with both immovable supraclavicular nodes and celiac nodes are excluded 4) No distant metastasis except for nonregional lymph node metastasis as mentioned in 3)-ii) 5) 60 Gy of definitive irradiation is considered to be possible without excessive radiation dose for risk organ 6) Age 20-75 years 7) Eastern Cooperative Oncology Group performance status (PS) of 0 or 1 8) No prior therapy against esophageal cancer except for complete resection by EMR/ESD 9) No prior chemotherapy, radiotherapy or hormonal therapy against any cancers except for hormonal therapy for prostate cancer with more than 5 years of disease-free interval, or for radical endoscopic resection for head and neck cancer or esophageal cancer 10) Adequate functioning of major organ systems 11) Written informed consent was obtained from each patient
Key exclusion criteria	1) Simultaneous or metachronous (within 5 years) double cancers, except for intramucosal tumor curatively resected by local therapy 2) Active infection requiring systemic therapy 3) Positive HBs antigen, HCV antibody or HIV antibody 4) Pregnant or lactating women or women of childbearing potential 5) Psychiatric disease 6) Patients requiring systemic steroids medication 7) Hypersensitivity for docetaxel, cisplatin or polysorbate 80 containing drug 8) Uncontrolled diabetes mellitus 9) Severe emphysema or pulmonary fibrosis 10) Unstable angina within 3 weeks, or with a history of myocardial infarction within 3 months. 11) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size	48

Research contact person
Name of lead principal investigator	Yukou Kitagawa
Organization	School of Medicine, Keio University
Division name	Department of Surgery
Address	35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan
TEL	03-3353-1211
Email	kitagawa@a3.keio.jp

Public contact
Name of contact person	Tomoya Yokota
Organization	Shizuoka Cancer Center
Division name	Division of Gastrointestinal Oncology
Address	1007 Shimonagakubo Nagaizumi Sunto-gun, Shizuoka 411-8777, Japan
TEL	055-989-5222
Homepage URL
Email	t.yokota@scchr.jp

Sponsor
Institute	Shizuoka Cancer Center
Institute
Department

Funding Source
Organization	Cancer Fundation
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	静岡県立静岡がんセンター、慶応義塾大学、国立がん研究センター中央病院、愛知県がんセンター中央病院、大阪医科大学、がん研有明病院、国立がん研究センター東病院、埼玉県立がんセンター、静岡県立総合病院、千葉県がんセンター、千葉大学、東海大学、栃木県立がんセンター

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 07 Month 01 Day
Last modified on	2017 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012950