UMIN-CTR Clinical Trial

Public title

Tri-modality strategy with Docetaxel plus five-fluorouracil and cisplatin (DCF) induction chemotherapy for locally advanced esophageal cancer

Acronym

Tri-modality strategy with DCF induction chemotherapy for locally advanced esophageal cancer (COSMOS)

Scientific Title

Tri-modality strategy with Docetaxel plus five-fluorouracil and cisplatin (DCF) induction chemotherapy for locally advanced esophageal cancer

Scientific Title:Acronym

Tri-modality strategy with DCF induction chemotherapy for locally advanced esophageal cancer (COSMOS)

Region

Japan

Condition

Esophageal cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery
Radiology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yukou Kitagawa

Organization

School of Medicine, Keio University

Division name

Department of Surgery

Zip code

Address

35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan

TEL

03-3353-1211

Email

kitagawa@a3.keio.jp

Name of contact person

1st name
Middle name
Last name	Tomoya Yokota

Organization

Shizuoka Cancer Center

Division name

Division of Gastrointestinal Oncology

Zip code

Address

1007 Shimonagakubo Nagaizumi Sunto-gun, Shizuoka 411-8777, Japan

TEL

055-989-5222

Homepage URL

Email

t.yokota@scchr.jp

Institute

Shizuoka Cancer Center

Institute

Department

Personal name

Organization

Cancer Fundation

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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　

Date of disclosure of the study information

2013

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Main results already published

Date of protocol fixation

2013

Year

04

Month

01

Day

Date of IRB

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

Other related information

Registered date

2013

Year

07

Month

01

Day

Last modified on

2017

Year

07

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012950