UMIN-CTR Clinical Trial

Basic information
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
Condition	Advanced Esophageal Cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Overall Survival(OS)
Key secondary outcomes	Safety Progression-free survival (PFS) Time to treatment failure (TTF) Response Rate (RR)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization	Osaka Clinical Study Supporting Organization
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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）

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 14 Day

Related information
URL releasing protocol	https://www.ejcancer.com/article/S0959-8049(21)00411-1/fulltext
Publication of results	Published

Result
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

Progress
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
Other related information

Management information
Registered date	2012 Year 05 Month 13 Day
Last modified on	2022 Year 11 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009350