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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006045
Receipt No. R000007155
Scientific Title A Randomized Phase II trial Comparing the XP and SP as the First-line Treatment for Advanced Gastric Cancer (XParTS II study)
Date of disclosure of the study information 2011/08/01
Last modified on 2019/01/10

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Basic information
Public title A Randomized Phase II trial Comparing the XP and SP as the First-line Treatment for Advanced Gastric Cancer (XParTS II study)
Acronym XParTS II study
(XP ascertainment vs. SP randomized PII study)
Scientific Title A Randomized Phase II trial Comparing the XP and SP as the First-line Treatment for Advanced Gastric Cancer (XParTS II study)
Scientific Title:Acronym XParTS II study
(XP ascertainment vs. SP randomized PII study)
Region
Japan Asia(except Japan)

Condition
Condition Gastric Cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to elucidate the efficacy and safety of XP and SP for first-line treatment of Advanced Gastric Cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Overall Survival,
Response Rate,
Time to Treatment Failure,
Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 SP arm:
S-1 at a dose of 80mg/m2/day orally in 2 divided doses for 3weeks on and 2week rest
Cisplatin at a dose of 60mg/m2 intravenously on day8 of every 5weeks
Interventions/Control_2 XP arm:
Capecitabine at a dose of 2,000mg/m2/day orally in 2 divided doses for 2weeks on and 1week rest
Cisplatin at a dose of 80mg/m2 intravenously on day1 of every 3weeks
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease
2) Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1)
3) No previous chemotherapy or radiotherapy. However, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy
4) ECOG Performance Status of 0 to 2
5) Life expectancy of at least 3 months after registration
6) Written informed consent
7) Age of 20 to 74 years with either gender
8) Adequate Major organ functions within 14 days before registration
Key exclusion criteria 1)Positive HER2 status
2)Previous history of fluoropyrimidine therapy within 6 months prior to registration
3)Previous treatment with platinum agents within 12 months prior to registration
4)Previous treatment with cisplatin more than total dose of 120 mg/m2
5)Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents
6)Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency
7)More than one cancer at the same time, or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment.
8)Obvious infection or inflammation (pyrexia &#61619; 38.0&#730;C)
9)Active hepatitis
10)Heart disease that is serious or requires hospitalization, or history of such disease within past year
11)Concurrent illness that is serious or requires hospitalization (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver disorders, or hepatic cirrhosis)
12)Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium
13)Chronic diarrhoea (watery stool &#61619; 4 times/day)
14)Active gastrointestinal haemorrhage
15)Body cavity fluids requiring drainage or other treatment
16)Clinical suspicion or previous history of metastases to brain or meninges
17)Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant
18)Unwillingness to practice contraception
19)Poor oral intake
20)Psychiatric disorders which are being or may need to be treated with psychotropics
21)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Tsuburaya
Organization Kanagawa Cancer Center
Division name Department of Gastrointestinal Surgery
Zip code
Address 1-1-2 Nakao, Asahi-ku, Yokohama-shi, Kanagawa, 241-0815
TEL 045-261-5656
Email tuburayaa@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yumi Miyashita
Organization Epidemiological and Clinical Research Information Network (ECRIN)
Division name Aichi Devision
Zip code
Address Sanshuya bldg. 2F, 348, Kouseicho, Okazaki, Aichi, 444-0052
TEL 0564-66-1220
Homepage URL
Email miya@ecrin.or.jp

Sponsor
Institute Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department

Funding Source
Organization Epidemiological and Clinical Research Information Network (ECRIN)
Organization
Division
Category of Funding Organization Non profit foundation
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 YES
Study ID_1 NCT01406249
Org. issuing International ID_1 US National Institutes of Health
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ejcancer.com/
Number of participants that the trial has enrolled
Results In 110 eligible patients, 24-week PFS was higher in both groups (SP 50.9%, XP 43.5%) than the protocol-specified threshold of 40%. The median PFS for SP versus XP was 5.6 and 5.1 months; OS was 13.5 and 12.6 months and the ORR was 42.4% and 69.4%, respectively. The most common grade 3 adverse events with SP/XP were anaemia (16%/20%), neutropenia (9%/18%) and anorexia (18%/13%). Subgroup analysis by histological classification showed no statistical difference between treatments.
Conclusions: XP and SP are comparable and can be recommended as control arms in a phase III study for AGC. Histological subtypes were not sensitive markers for the selection of XP or SP.
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

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 26 Day
Last modified on
2019 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007155

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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