UMIN-CTR Clinical Trial

Public title

Phase I/II Study of Chemoradiotherapy with Paclitaxel for Elderly Stage IB-III Esophageal Cancer

Acronym

Phase I/II Study of Chemoradiotherapy with Paclitaxel for Elderly Esophageal Cancer

Scientific Title

Phase I/II Study of Chemoradiotherapy with Paclitaxel for Elderly Stage IB-III Esophageal Cancer

Scientific Title:Acronym

Phase I/II Study of Chemoradiotherapy with Paclitaxel for Elderly Esophageal Cancer

Region

Japan

Condition

Esophageal Cancer

Classification by specialty

Medicine in general	Gastroenterology	Geriatrics
Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

<Phase I>
To determine the recommended dose of Paclitaxel for elderly Stage IB-III esophageal cancer patients in chemoradiotherapy with Paclitaxel.

<Phase II>
To evaluate safety and efficacy of the recommended dose of chemoradiotherapy with Paclitaxel in elderly Stage IB-III esophageal cancer patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

<Phase I>
The frequency of DLT (Dose Limiting Toxicity)

<Phase II>
Two year survival rate

Key secondary outcomes

<Phase I>
Adverse event, Overall survival, Progression-free survival, Complete response rate, Pharmacokinetics, Geriatric Assessment

<Phase II>
Complete response rate, Progression-free survival, Adverse event, Late toxicity, Pharmacokinetics, Geriatric Assessment

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

Other

Interventions/Control_1

Paclitaxel 30-60mg/m2 (day1, 8, 15, 22, 29, 36)
or 40-60mg/m2 (day1, 15, 29)

Radiation 60Gy/30fr

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

70

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma or basaloid cell carcinoma.
2) Primary tumor located in thoracic esophagus. Second tumors in cervical or abdominal esophagus which is indicated for EMR/ESD are also eligible.
3) Clinical stages IB, II or III (excluding T4) based on the 7th UICC-TNM classification.
4) Patients who are amenable to 60Gy radiation therapy.
5) >=70 years old.
6)
i) >=70 and <80 year-old-patient, PS (ECOG) of 0 or 1, and Creatinine>=1.5mg/dl.
ii) >=70 and <80 year-old-patient, PS (ECOG) of 2.
iii) >=80 year-old-patient, PS (ECOG) of 0 and 1.
7) Patients have measurable and/or non-measurable disease according to RECIST ver1.1.
8) No prior treatment against esophageal cancer except for endoscopic resection.
9) No prior chemotherapy and radiation therapy.
10) Sufficient organ functions.
i) Neutrophil >= 1500/mm3
ii) WBC < 12000/mm3
iii) Platelet >= 100000/mm3
iv) T.Bil =< 1.5mg/dL
v) AST =< 100IU/L
vi) ALT =< 100IU/L
11) refused esophagectomy.
12) Written informed consent.

Key exclusion criteria

1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Infectious disease with systemic therapy indicated.
3) Severe psychiatric disease.
4) Continuous systemic steroid therapy.
5) Poorly controlled diabetes mellitus.
6) Severe pulmonary fibrosis or emphysema.
7) Unstable angina pectoris, or history of myocardial infarction within three months.
8) Other conditions not suitable for this study.

Target sample size

74

Name of lead principal investigator

1st name
Middle name
Last name	Yuko Kitagawa

Organization

Keio University School of Medicine

Division name

Surgery

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-1211

Email

kitagawa@a3.keio.jp

Name of contact person

1st name
Middle name
Last name	Yasuo Hamamoto, Kenro Hirata

Organization

Keio University School of Medicine

Division name

Gastroenterology and Hepatology

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-1211

Homepage URL

Email

kenro916@gmail.com

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

None

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

2016

Year

01

Month

01

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

10

Month

16

Day

Date of IRB

Anticipated trial start date

2016

Year

04

Month

21

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

12

Month

29

Day

Last modified on

2016

Year

05

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022521