UMIN-CTR Clinical Trial

Public title

Randomized phase II trial of DCF-R vs CF-R in unresectable and recurrent esophageal cancer

Acronym

Randomized phase II trialof DCF-R vs CF-R

Scientific Title

Randomized phase II trial of DCF-R vs CF-R in unresectable and recurrent esophageal cancer

Scientific Title:Acronym

Randomized phase II trialof DCF-R vs CF-R

Region

Japan

Condition

unresectable and recurrent esophageal cancer

Classification by specialty

Medicine in general	Gastroenterology	Hematology and clinical oncology
Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We evaluateWe evaluate safety and efficacy of DCF-R and CF-R.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Complete response rate

Key secondary outcomes

overall survival rate, progression free survival rate, response rate, disease control rate, toxicity

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

DCF-R Docetaxel (50mg/m2)day1,29, CDDP(60mg/m2) day1,29, 5-FU(600mg/m2)day1-4, 29-32 Radiation 2Gy30times

Interventions/Control_2

CF-R CDDP(70mg/m2) day1,29, 5-FU(700mg/m2)day1-4, 29-32 Radiation 2Gy30times

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)The histologiy or cytology of the esophageal cancer (squamous cell carcinoma, adenocarcinoma) is confirmed.
2)The unresectable or recurrence cancer of the esophagus.
3)The age at registration is less than 75 years old 20 years old or older
4)PS(ECOG) is a case of 0 or 1.
5)A case (it is not said that the measurable lesion is required) that an evaluable lesion is confirmed with objective documents such as CT, MRI, X-ray within 30th before registration.
6)The case that did not undergo chemotherapy or radiotherapy in unresectable cancer of the esophagus.
But we allow only for a case to be more than 180 days after last dosage day when adjuvant chemotherapy is enforced after surgery.
7)The case that the following main organ functions are secured for less than 14 days before registration by inspection of (possible as for the inspection of the same day two weeks before the registration day).
1)A white blood-cell count: It is less than 12,000 /mm3 more than 3,000 /mm3
2)A neutrophilic number: More than 1,500 /mm3
3)The number of the platelets: More than 100,000 /mm3
4)Hemoglobin: More than 9.0 g/dL
5)Total bilirubin: Lower than 2.0 mg/dL
6)AST (GOT): 100IU/L or less
7)ALT (GPT):) 100IU/L or less
8)Serum creatinine: Lower than 1.2 mg/dL
9)Creatinine clearance: It is more than 60 mL/min
When I measure creatinine clearance by the urine collection for 24 hours, I use the value.
When there is not an actual value, I calculate an estimate using a following Cockcroft-Gault estimates type.
Creatinine clearance estimate =(the (140-age) X weight)/ [72* serum creatinine level] (do a value provided in the case of a woman more 0.85 times)
8)The case that survival more than three months is expected.
9)The case that a written agreement is provided from a patient.

Key exclusion criteria

1)The patients with a history of severe drug hypersensitivity.
2)Pregnant women or women that might be pregnant. Men who wish to partner pregnancy.
3)patients with active infection (fever over 38 degree).
4)cases of serious complications (interstitial pneumonia or pulmonary fibrosis, kidney failure, liver failure, poor control of diabetes, control such as failure of the high blood pressure).
5)significant ECG abnormalities are observed cases or heart disease (heart failure to be a clinical problem, myocardial infarction, patients with angina pectoris).
6)the active gastrointestinal tract ulcers or patients with bleeding.
7)patients with sensory neuropathy.
8)Serious cases of diarrhea.
9)patients with ascites and pleural effusion requiring drainage by continuous drainage detention.
10)patients with brain metastases or case to suspect brain metastases from clinical symptoms
11)patient with cancer of less than five years disease-free period (healing skin basal cell cancer and cervical cancer or endoscopic mucosal resection by healing, it has been confirmed, esophageal cancer, colon pM cases of cancer I and registration available).
12)patients undergoing continuous systemic administration of steroids.
cases
13)attending physician is considered unsuitable for participation in the study.
14)Docetaxel, case is the administration contraindication of CDDP, 5-FU.

Target sample size

52

Name of lead principal investigator

1st name
Middle name
Last name	Miyazaki Tatsuya

Organization

Gunma University Hospital

Division name

Integrative center of general surgery

Zip code

Address

3-39-15 Showa-machi Maebashi-shi Gunma Japan

TEL

027-220-8224

Email

tatsuyamiyazaki@gunma-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Miyazaki Tatsuya

Organization

Gunma University Hospital

Division name

Integrative center of general surgery

Zip code

Address

3-39-15 Showa-machi Maebashi-shi Gunma Japan

TEL

027-220-8224

Homepage URL

Email

tatsuyamiyazaki@gunma-u.ac.jp

Institute

Gunma University Hospital Integrative center of general surgery

Institute

Department

Personal name

Organization

Gunma University Hospital Integrative center of general surgery

Organization

Division

Category of Funding Organization

Self funding

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

Date of disclosure of the study information

2015

Year

07

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Open public recruiting

Date of protocol fixation

2015

Year

07

Month

01

Day

Date of IRB

Anticipated trial start date

2015

Year

07

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

07

Month

27

Day

Last modified on

2015

Year

07

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021146