UMIN-CTR Clinical Trial

Public title

Randomized Phase II trial of Docetaxel treatment vs Paclitaxel
Treatment for advanced/metastatic esophageal cancer resistant to fluoropyrimidine and/or platinum compound (OGSG1201)

Acronym

Second line treatment using taxan in esophageal cancer (OGSG1201)

Scientific Title

Randomized Phase II trial of Docetaxel treatment vs Paclitaxel
Treatment for advanced/metastatic esophageal cancer resistant to fluoropyrimidine and/or platinum compound (OGSG1201)

Scientific Title:Acronym

Second line treatment using taxan in esophageal cancer (OGSG1201)

Region

Japan

Condition

Advanced Esophageal Cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of Docetaxel and/or paclitaxel as the second line treatment for unresectable advanced esophageal cancer resistant to fluoropyrimidine and/or platinum compound

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

Overall Survival(OS)

Key secondary outcomes

Safety
Progression-free survival (PFS)
Time to treatment failure (TTF)
Response Rate (RR)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Docetaxel: 70 mg/m2 on day 1 every 3 week

Interventions/Control_2

Paclitaxel: 100 mg/m2 on day 1,7, 14, 21, 28, 35 and subsequent 7 days rest,
repeat every 7 week

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) Histologically confirmed esophageal squamous/adenosquamous cancer
2) Advanced and/or recurrent esophageal cancer resistant to fluoropyrimidine and/or platinum compound
3) Without prior chemotherapy using Taxans (Docetaxel or Paclitaxel)
4) The age of 20 or over and under the age of 80
5) PS(ECOG) 0,1 or 2
6) expected survival longer than 3 months from the start of regimen
7) a treatment interval longer than 14 days
8) Adequate baseline organ and marrow function as defined below by a test within 7 days of registration;
a)Leukocytes: 3,500-12,000 /mm3
b)Absolute neutrophil count: >=2,000 / mm3
c)Platelets: >=100,000 / mm3
d)Hemoglobin: >=9.0 g/dL
e)AST (SGOT)/ALT (SGPT) < 100 IU/L
f)Total bilirubin <1.5 mg/dL
g)Serum creatine >=1.2 mg/dL
h)Creatinine clearance: >=60 mL/min
9) with HBs Ag (-) confirmed by a test within 1 year of registration
10) Patients should sign a written informed consent
11) All the conditions by inspection within 7th before registration

Key exclusion criteria

1) With active double cancers (Simultaneous and/or prior cancer within 5 years)
Except cancers resected completely by ER/ESD
2) With uncontrolled DM
3) With cardiac infarction within 6 months or unstable angina pectoris
4) Patients who are administered anti-arhythmia except Warfarin
5) Patients who are administered steroids continuously orally and/or intravenously
6) Patient with liver cirrhosis
7) Patient with active infection
8) Patients with peri-cardiac fluid, pleural fluid and/or ascites which needs drainage
Except controlled pleural fluid or ascites
9) With a history of grade 2-4 allergic reaction
By CTCAE version 4.0
10) with a history of grade 2-4 nerve disturbance by CTCAE version 4.0
11) with blood transfusion within 2 weeks and/or continuous bleeding
12) with a figure of interstitial pneumonitis except radiation pneumonitis
13) with a history of allergic reaction to
polyoxyethylene-castor oil, castor oil or
polysolbate 80
14) with metastatic lesion in the central nerve
system
15) patient with psychological disorder who cannot participate in this regimen
16) women pregnant and/or nursing or men who like to have children in future
17) Any patients judged by the investigator to be unfit to participate in the study

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Sachiko Yamamoto

Organization

Osaka International Cancer Institute

Division name

Department of Cancer Chemotherapy

Zip code

Address

3-1-69, Otemae, chuoh-ku, Osaka, 541-8567, Japan

TEL

06-6945-1181

Email

yamamoto-sa@mc.pref.osaka.jp

Name of contact person

1st name
Middle name
Last name	Sachiko Yamamoto

Organization

Osaka International Cancer Institute

Division name

Department of Cancer Chemotherapy

Zip code

Address

3-1-69, Otemae, chuoh-ku, Osaka, 541-8567, Japan

TEL

06-6945-1181

Homepage URL

Email

yamamoto-sa@mc.pref.osaka.jp

Institute

Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)

Institute

Department

Personal name

Organization

Osaka Clinical Study Supporting Organization

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

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

大阪国際がんセンター（大阪府）、大阪医科大学（大阪府）、埼玉県立がんセンター（埼玉県）、大阪府立急性期総合医療センター（大阪府）、北野病院（大阪府）、八尾市立病院（大阪府）、大阪労災病院（大阪府）、堺市立総合医療センター（大阪府）、近畿大学病院（大阪府）、神戸市立医療センター中央病院（兵庫県）、関西労災病院（兵庫県）、市立東大阪医療センター（大阪府）、神戸大学（兵庫県）、関西電力病院（大阪府）、香川大学（香川県）

Date of disclosure of the study information

2012

Year

05

Month

14

Day

URL releasing protocol

https://www.ejcancer.com/article/S0959-8049(21)00411-1/fulltext

Publication of results

Published

URL related to results and publications

https://www.ejcancer.com/article/S0959-8049(21)00411-1/fulltext

Number of participants that the trial has enrolled

80

Results

OS was significantly longer in the PTX group than in the DTX group (median, 8.8 versus 7.3 months; hazard ratio [HR], 0.62; P = 0.047).

Results date posted

2022

Year

11

Month

05

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2021

Year

07

Month

23

Day

Baseline Characteristics

esophageal squamous cell carcinoma (ESCC) refractory to first-line fluoropyrimidine- and platinum-based chemotherapy

Participant flow

Seventy-eight eligible patients (N = 39 in each group) were included for efficacy analysis.

Adverse events

Compared to the PTX group, neutropenia (28% versus 80%) and leukopenia (28% versus 76%) of grade >=3 as well as febrile neutropenia (0% vs. 46%, P < 0.0001) occurred more frequently in the DTX group.

Outcome measures

The primary end-point was overall survival (OS), and secondary endpoints included progression-free survival (PFS), time to treatment failure (TTF), response rate (RR), and safety.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2012

Year

04

Month

23

Day

Date of IRB

2012

Year

06

Month

27

Day

Anticipated trial start date

2012

Year

07

Month

11

Day

Last follow-up date

2020

Year

04

Month

21

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2020

Year

11

Month

30

Day

Other related information

Registered date

2012

Year

05

Month

13

Day

Last modified on

2022

Year

11

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009350