UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Study to Evaluate Efficacy and Safety of Capecitabine + Cisplatin Combination Therapy in Gastric Cancer Patients Who Relapsed After S-1 Adjuvant Chemotherapy
Title of the study (Brief title)	XParTS study
Region	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	To evaluate the efficacy and safety of capecitabine + cisplatin combination therapy in first line treatment of gastric cancer patients who relapsed less than 6 months after S-1 based adjuvant chemotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression-free survival (PFS)
Key secondary outcomes	Overall survival (OS), Overall response rate (ORR), Time to treatment failure (TTF), Severity and incidence of adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	capecitabine + cisplatin combination therapy
Interventions/Control_2
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)Recurrent gastric cancer histologically confirmed as being adenocarcinoma 2)Between the ages of 20 and 74 years at the time informed consent is obtained 3)Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 4)Lesions confirmed on imaging within 28 days before registration (not required measurable lesions) 5)Post-gastrectomy adjuvant chemotherapy including S-1 for at least 12 weeks including interruption period 6)Less than 6 months treatment free interval from completion of adjuvant therapy 7)Treatment-naive recurrent gastric cancer 8)Life expectancy of at least 3 months after registration 9)Personal written informed consent obtained after study fully explained 10)Major organ functions meet the criteria within 14 days before registration
Key exclusion criteria	1)Positive HER2 status 2)Previous treatment with platinum agents 3)Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents 4)Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency 5)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. 6)Obvious infection or inflammation 7)Active hepatitis 8)Heart disease that is serious or requires hospitalization, or history of such disease within past year 9)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) 10)Being treated or in need of treatment with phenytoin or warfarin potassium 11)Chronic diarrhoea (watery stool or 4 times or more/day) 12)Active gastrointestinal haemorrhage 13)Body cavity fluids requiring drainage or other treatment 14)Clinical suspicion or previous history of metastases to brain or meninges 15)Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant 16)Unwillingness to practice contraception 17)Poor oral intake 18)Psychiatric disorders which are being or may need to be treated with psychotropics 19)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
Target sample size	40

Research contact person
Name of lead principal investigator	Akira Tsuburaya
Organization	Kanagawa Cancer Center
Division name	Department of Gastrointestinal Surgery
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	Yumi Miyashita
Organization	Epidemiological and Clinical Research Information Network (ECRIN)
Division name	Aichi Devision
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)

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT01412294
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 06 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 05 Month 25 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date	2016 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://link.springer.com/article/10.1007%2Fs10120-018-0815-0
Results	Forty patients (median age: 64) were enrolled; of those, 37 (92.5%) received adjuvant S-1 monotherapy. Median PFS was 4.4 months, which was longer than the 2-month protocol-specified threshold (p<0.001). Median OS was 13.7 months (95% CI, 9.0-17.7) and ORR was 8/30 (26.7%). Most common grade=>3 adverse events were neutropenia (23%), anemia (18%), elevated serum creatinine (18%), fatigue (13%), diarrhea (7.5%), and anorexia (7.5%). Conclusions: XP was safe and effective in patients with early relapse after S-1 adjuvant chemotherapy for curatively resected gastric cancers.
Other related information

Management information
Registered date	2011 Year 06 Month 27 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/icdr_e/ctr_view.cgi?recptno=R000006919