UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005857 |
|---|---|
| Receipt number | R000006919 |
| Scientific Title | Phase II Study to Evaluate Efficacy and Safety of Capecitabine + Cisplatin Combination Therapy in Gastric Cancer Patients Who Relapsed After S-1 Adjuvant Chemotherapy |
| Date of disclosure of the study information | 2011/06/30 |
| Last modified on | 2019/01/10 16:25:54 |
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Basic information
Public title
Phase II Study to Evaluate Efficacy and Safety of Capecitabine + Cisplatin Combination Therapy in Gastric Cancer Patients Who Relapsed After S-1 Adjuvant Chemotherapy
Acronym
XParTS study
Scientific Title
Phase II Study to Evaluate Efficacy and Safety of Capecitabine + Cisplatin Combination Therapy in Gastric Cancer Patients Who Relapsed After S-1 Adjuvant Chemotherapy
Scientific Title:Acronym
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
| 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
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
miya@ecrin.or.jp
Sponsor or person
Institute
Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department
Personal name
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
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs10120-018-0815-0
Number of participants that the trial has enrolled
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.
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 | 05 | Month | 25 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006919
