UMIN-CTR Clinical Trial

Public title

Clinical Phase I / II trial of weekly docetaxel therapy in conjunction with radiation in case of FP therapy refractory cases in esophageal cancer

Acronym

Clinical Phase I / II trial of weekly docetaxel therapy in conjunction with radiation in case of FP therapy refractory cases in esophageal cancer

Scientific Title

Clinical Phase I / II trial of weekly docetaxel therapy in conjunction with radiation in case of FP therapy refractory cases in esophageal cancer

Scientific Title:Acronym

Clinical Phase I / II trial of weekly docetaxel therapy in conjunction with radiation in case of FP therapy refractory cases in esophageal cancer

Region

Japan

Condition

Esophageal cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Phase I part:
We clarified the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of docetaxel dose of docetaxel in simultaneous radiation combination therapy in patients with refractory / intolerant FP therapy in esophageal cancer and recommended one dose lower than MTD Dose (RD) is taken.
Phase II part:
For 40 cases (including Phase I), treat with docetaxel recommended dose and evaluate the efficacy and safety of docetaxel therapy combined with radiation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

phase 1 part:
DLT expression rate
phase 2 part:
Response rate

Key secondary outcomes

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

Phase 1 part:
The dose of docetaxel is initially set at 10mg /m2/day (level1) and the number of cases is increased and the dose escalation is increased by5mg/m2/day according to the expression status of dose limiting toxicity (DLT) in one cycle. We administered 3 cases at each level, and after 1 cycle of the final case, based on the results of all cases to which said dose was administered, shift to the next level add the number of cases judge the maximum tolerated dose
Phase 2 part
In phase II, chemoradiotherapy is performed in a new case using the recommended dosage of docetaxel obtained in Phase I part. The safety and effectiveness of the test treatment are judged by periodically conducting an image such as blood test or CT or upper gastrointestinal endoscopy

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) The primary lesion is either cervical or thoracic esophagus (TNM classification).
2) Histopathologically it has been diagnosed as squamous cell carcinoma.
3) FP therapy refractory / intolerance.
4) The age of the registration date is 20 years old to 80 years old.
5) ECOG Performance status is 0 to 2.
6) Organ function is maintained.
7) There is no symptomatic brain metastasis.
8) Patients with a history of operation had esophageal cancer for total esophageal cancer cases in which more than 2 weeks had passed since gastric tube reconstruction
9) Cases in which survival is predicted to be at least 3 months or more from the date of registration
10) Cases in which an examination value within 14 days before registration (not including the registration date) satisfies the following criteria
Hemoglobin 8.0 g / dL or more
White blood cell 3,000 to 13,000 / mm 3
Neutrophils 1,500 / mm 3 or more
Platelets 100,000 / mm 3 or more
Total bilirubin 1.5 mg / dL or less
AST 100 IU / L or less, provided that it has liver metastasis, up to 5 times the upper limit of the facility reference value is allowed
ALT 100 IU / L or less, provided that it has liver metastasis, up to 5 times the upper limit of the facility reference value is allowed
11) Hospitalization treatment and outpatient treatment are not limited
12) Regarding the participation of this study, consent from the person in writing is obtained.

Key exclusion criteria

1) Patients receiving transfusions, blood products and hematopoietic factor preparations such as G-CSF within 14 days before registration
2) Cases with infections or diseases requiring systemic administration of antibiotics, antifungal agents
3) Cases with complications as shown below
Control poor hypertension, diabetes
Severe lung disease (interstitial pneumonia, pulmonary fibrosis, advanced emphysema, etc.)
Liver failure
Gastrointestinal bleeding that requires treatment
4) Patients with marked electrocardiogram abnormality or cases with clinically problematic heart disease
Cases with congestive heart failure, symptomatic coronary artery disease, poorly controlled arrhythmia, a history of myocardial infarction that developed within the last 12 months, etc
5) Cases with psychiatric disorder judged by the investigator or test sharing doctor to have acquired consent or adversely affect test performance
Control malfunctioning epileptic seizures, central nervous system disorders, etc.
6) Cases with moderate or more ascites (above the pelvic cavity) or with large pleural effusions
7) Cases with brain metastasis or suspected brain metastasis from clinical symptoms
8) Cases with extensive bone metastases
9) Cases with active duplicated cancers
10) HIV antibody positive cases
11) Patients who received treatment with another study drug within 4 weeks before registration of this study or participate in other clinical trials (incidental study of this study "Esophageal cancer chemical radiation by genetic analysis Clinical research on susceptibility of therapy and prediction of side effects "excluding)
12) Cases judged unsuitable as subjects of the examination by the investigator

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Kazumi Hayashi

Organization

The Jikei University school of medicine

Division name

Department of Hematology and Oncology

Zip code

Address

3-25-8 Nishi-shinbashi minatoku tokyo

TEL

0334331111

Email

ms01-hayashi@jikei.co.jp

Name of contact person

1st name
Middle name
Last name	Kazumi Hayashi

Organization

The Jikei University school of medicine

Division name

Department of Hematology and Oncology

Zip code

Address

3-25-8 Nishi-shinbashi minatoku tokyo

TEL

0334331111

Homepage URL

Email

ms01-hayashi@jikei.co.jp

Institute

The Jikei University school of medicine

Institute

Department

Personal name

Organization

self funding

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

2017

Year

12

Month

27

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

2017

Year

09

Month

11

Day

Date of IRB

Anticipated trial start date

2017

Year

09

Month

11

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

12

Month

27

Day

Last modified on

2017

Year

12

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034936