臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 06, 2019
Last modified on	June. 10, 2021
Trial ID	jRCTs031180193

Scientific Title	JCOG1201/TORG1528: A Phase II/III Study Comparing Carboplatin and Irinotecan (CI) with Carboplatin and Etoposide (CE) for the Treatment of Elderly Extended-Stage Small-Cell Lung Cancer (Elderly ED-SCLC/CI vs. CE)
Public Title	JCOG1201/TORG1528: A Phase II/III Study Comparing Carboplatin and Irinotecan (CI) with Carboplatin and Etoposide (CE) for the Treatment of Elderly Extended-Stage Small-Cell Lung Cancer (Elderly ED-SCLC/CI vs. CE)

Completion date	Mar. 16, 2021
Result actual enrolment	258
Baseline Characteristics	Please find the "JCOG1201/TORG1528 clinical study report" file in the "Attached files: statistical analysis plan" section below. You will also find the "statistical analysis plan" file in the same section.
Participant flow	Please find the "JCOG1201/TORG1528 clinical study report" file in the "Attached files: statistical analysis plan" section below. You will also find the "statistical analysis plan" file in the same section.
Adverse events	Please find the "JCOG1201/TORG1528 clinical study report" file in the "Attached files: statistical analysis plan" section below. You will also find the "statistical analysis plan" file in the same section.
Outcome measures	Please find the "JCOG1201/TORG1528 clinical study report" file in the "Attached files: statistical analysis plan" section below. You will also find the "statistical analysis plan" file in the same section.
Brief summary	Efficacy tended to be favorable in carboplatin plus irinotecan arm, but there was no statistically significant difference in overall survival. These results indicate that carboplatin plus etoposide is still a standard treatment in elderly Japanese patients with extensive small-cell lung cancer.
Date of posting of results summaries	June. 10, 2021
Date of the first journal publication of results	April. 22, 2023
URL hyperlink(s) related to results and publications	https://doi.org/10.1016/j.lungcan.2023.107195

Plan to share IPD	No
Plan description	None
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs031180193

Contact for Scientific Queries	Name	OKAMOTO Hiroaki
	Affiliation	Yokohama Municipal Citizen's Hospital
	Address	1-1 Mitsuzawanishimachi,Kanagawa-ku,Yokohama-shi,Kanagawa ,221-0855 Japan
	Telephone	+81-45-316-4580
	E-mail	hi01-okamoto@city.yokohama.jp
Contact for Public Queries	Name	SHIMOKAWA Tsuneo
	Affiliation	Yokohama Municipal Citizen's Hospital
	Address	1-1 Mitsuzawanishimachi,Kanagawa-ku,Yokohama-shi,Kanagawa ,221-0855 Japan
	Telephone	+81-45-316-4580
	E-mail	ts00-shimokawa@city.yokohama.jp

Recruitment status	Complete

Anticipated date of first enrollment		Dec. 17, 2013
Actual date of first enrollment		Feb. 03, 2014
Target sample size		256
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Histologically or cytologically confirmed small-cell lung cancer 2) Extended-disease 3) No serious tumor related complications 4) 71 years of age or older 5) ECOG performance status of 0 to 2 6) With measurable lesions 7) No prior surgery, radiotherapy, or chemotherapy for small-cell lung cancer 8) No prior thoracic radiotherapy or chemotherapy for any other cancers within a year of enrollment 9) Adequate organ functions 10) No diarrhea, intestinal obstruction or past history of intestinal obstruction 11) Written informed consent
	Exclusion Criteria	1) Synchronous or metachronous (within 1 years) malignancies 2) Active infection requiring systemic therapy 3) Body temperature >= 38 degrees Celsius 4) Psychiatric disease 5) Patients requiring systemic steroid medication (>= 5 mg/day of prednisolone) 6) Poorly controlled diabetes mellitus (HbAic >= 8.0%) 7) Poorly controlled hypertension 8) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months 9) Interstitial pneumonia or pulmonary fibrosis
	Age Minimum	71age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Elderly patients with extended-stage small-cell lung cancer
Intervention(s)		Arm A:CBDCA+ETP(Every 3 weeks X 4 courses),CBDCA:AUC 5,day 1 ETP:80 mg/m2,day 1-3 Arm B:CBDCA+irinotecan(Every 3 weeks X 4 courses),CBDCA:AUC 4,day 1 irinotecan:50mg/m2,day 1,8
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Phase III: Overall survival, Phase II: Response rate of CI arm
Secondary Outcome(s)		Phase III: Progression-free survival, Response rate, Adverse events, Serious adverse events, Symptom score Phase II: Adverse events

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	National Cancer Center Japan
Secondary Sponsor	Not applicable

Source of Monetary Support	Ministry of Health, Labour and Welfare
Secondary Sponsor	Not applicable

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	National Cancer Center Hospital East Certified Review Board
Address	6-5-1 Kashiwanoha, Kashiwa, Chiba
Telephone	+81-4-7133-1111
E-Mail	ncche-irb@east.ncc.go.jp
Approval Status	Approval
Date of approval	Dec. 06, 2018

Secondary ID(s)	UMIN000012605
Issuing Authority	UMIN Clinical Trials Registry (UMIN-CTR)

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	June. 10, 2021	(this page)	Changes
5	Oct. 06, 2020	Detail	Changes
4	April. 13, 2020	Detail	Changes
3	Sept. 16, 2019	Detail	Changes
2	April. 25, 2019	Detail	Changes
1	Mar. 06, 2019	Detail

List of change history