UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000677
Receipt number R000000814
Scientific Title Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701)
Date of disclosure of the study information 2007/04/19
Last modified on 2021/11/14 18:11:33

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Basic information

Public title

Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701)

Acronym

Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701)

Scientific Title

Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701)

Scientific Title:Acronym

Randomized phase II study of CPT-11 versus TXL versus each combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy (OGSG 0701)

Region

Japan


Condition

Condition

progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the effectiveness and feasibility among CPT-11, TXL or combination chemotherapy with TS-1 against progressed/relapsed gastric cancer after TS-1 or TS-1/platinum compounds(CDDP or OHP) chemotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival time.

Key secondary outcomes

To determine the qualitative and quantitative toxicity and reversibility of toxicity of each chemotherapeutic regimen.
To estimate antitumor activity.
To estimate the progression free survival time.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment

Central registration


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A:CPT-11(150mg/m2/day,day1) every 2 weeks

Interventions/Control_2

B:TXL (80mg/m2, day1,8,15) every 4 weeks

Interventions/Control_3

C:TS-1 (80-120mg/day, day1-21), CPT-11(80mg/m2/day, day1,15) every 5 weeks.

Interventions/Control_4

D:TS-1 (80-120mg/day, day1pm~day15am), TXL( 50mg/m2/day, day1,8) every 3 weeks.

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Patients who have not received prior antitumor chemotherapies without S-1 or S-1/CDDP treatment, immunotherapy, or radiotherapy (including local irradiation for pain control) as primary chemotherapy.
2) Patients who had received resistant for prior antitumor chemotherapy with S-1 or S-1/CDDP treatment as primary chemotherapy in whom either (a) or (b) below are diagnosed to be present by the principal investigator of the trial.
(a) Advanced gastric cancer in which a new lesion or progression has been observed by diagnostic imaging after TS-1 monotherapy or TS-1/CDDP combination chemotherapy (either therapy for 4weeks or more) as primary chemotherapy for gastric cancer.
(b) Recurrence during postoperative chemotherapy by TS-1 monotherapy or within 26 weeks of its completion.
3) Patients in whom at least 2 weeks has passed since the completion of the previous chemotherapy.
4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 1, 2 or less.
5) A predicted life expectancy of at least 3 months.
6) Preservation of major organ function to satisfy the following : leukocyte count of >=4,000 to <12,000 mm3 ; platelet count of >= 100,000/mm3 ; hemoglobin of >=8.0 g/dl ; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels of <=100 IU/l *Except that even if the AST or ALT value does not fulfill this criterion, if the value is diagnosed to be attributable to the primary disease, such as liver metastasis, the criterion will be no more than 150 IU/l. ; alkaline phosphatase of <=x2 the upper limit of the normal range (ULN) ; serum bilirubin level of <=1.5 mg/dl ; serum creatinine of <=1.2 mg/dl or creatinine clearance level of >=50ml/min (When available, the actual measurement will be used as the eligibility criterion, but the value obtained by using the Cockcroft-Gault formula can also be used)
7) Written informed consent to participate in this study

Key exclusion criteria

1) Have a double cancer patient
2) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc.
3) Infectious disease
4) Diarrhea (watery stools)
5) Ascites or pleural effusion
6) History of serious drug hypersensitivity (especially such as cyclosporine preparations, containing polyoxyethylene castor oil [Cremophor EL], or such as [vitamin preparations for injection] containing hydrogenated castor oil.
7) Undergoing treatment with other fluoropyrimidine anticancer agents, fluorocytosine, or atazanavir sulfate.
8) Found to have fresh gastrointestinal bleeding that requires repeated transfusion.
9) With liver cirrhosis or jaundice.
10) Undergoing treatment with a psychotropic agent or who have a mental disorder that seems to require treatment.
11) having heart disease, such as ischemic heart disease or an arrhythmia, severe enough to require treatment.
12) With diabetes that is difficult to control.
13) With central nervous system metastasis
14) Pregnant, breast-feeding, or who wish to undergo artificial insemination
15) Any other patient whom the physician in charge of the study judges to be unsuitable

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Imamura Hiroshi

Organization

Sakai City Hospital

Division name

Department of surgery

Zip code


Address

1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064

TEL

072-221-1700

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Furukawa

Organization

Kinki University Faculty of Medicen

Division name

Department of surgery

Zip code


Address

377-2, Onohigashi, Osakasayama, Osaka, Japan

TEL

072-366-0221

Homepage URL


Email



Sponsor or person

Institute

Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)

Institute

Department

Personal name



Funding Source

Organization

Osaka Clinical Study Supporting Organization

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2007 Year 04 Month 19 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007%2Fs10147-021-01984-y

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007%2Fs10147-021-01984-y

Number of participants that the trial has enrolled

127

Results

No difference in median OS was observed in the irinotecan vs. paclitaxel groups or in the monotherapy groups vs. the S-1 combination therapy groups for advanced gastric cancer (AGC). Median PFS was longer in the paclitaxel group compared with the irinotecan group (4.1 vs. 3.6 months, p = 0.035), although no difference was observed when comparing monotherapy vs. S-1 combination.

Results date posted

2021 Year 11 Month 14 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 08 Month 28 Day

Baseline Characteristics

Patient for advanced gastric cancer (AGC) that is refractory to S-1 or S-1 plus CDDP (SP)

Participant flow

Patients with AGC after first-line chemotherapy with S-1 or SP, or patients during adjuvant chemotherapy, or within 26 weeks after adjuvant chemotherapy completion with S-1 with confirmed disease progression were eligible. Patients were randomly divided into four groups based on treatment.
From July 2008 to March 2012, 127 patients were enrolled.

Adverse events

The most common grade 3 to 4 hematological adverse events were neutropenia with no difference in incidence rate across the treatment groups.

Outcome measures

overall survival

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2007 Year 02 Month 19 Day

Date of IRB

2007 Year 04 Month 10 Day

Anticipated trial start date

2007 Year 07 Month 24 Day

Last follow-up date

2014 Year 03 Month 08 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2014 Year 07 Month 28 Day


Other

Other related information



Management information

Registered date

2007 Year 04 Month 12 Day

Last modified on

2021 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000814


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name