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XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
SP
XP
Sponsored by
Epidemiological and Clinical Research Information Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring unresectable gastric cancer, recurrent gastric cancer, StageIV gastric cancer, adenocarcinoma of the stomach, XP, SP

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

  1. Positive HER2 status
  2. Previous history of fluoropyrimidines therapy within 6 months prior to registration
  3. Previous treatment with platinum agents
  4. Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents
  5. Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency
  6. 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.
  7. Obvious infection or inflammation (pyrexia ≥ 38.0˚C)
  8. Active hepatitis
  9. Heart disease that is serious or requires hospitalization, or history of such disease within past year
  10. Having complication 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)
  11. Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium
  12. Chronic diarrhea (watery stool or ≥4 times/day)
  13. Active gastrointestinal bleeding
  14. Body cavity fluids requiring drainage or other treatment
  15. Clinical suspicion or previous history of metastasis to brain or meninges
  16. Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant
  17. Unwillingness to practice contraception
  18. Poor oral intake
  19. Psychiatric disorders which are being or may need to be treated with psychotropics
  20. Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study

Sites / Locations

  • Epidemiological and Clinical Research Information Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

S-1,Cisplatin

Capecitabine, Cisplatin

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival rate

Secondary Outcome Measures

Time-to treatment failure
Response rate
Overall survival
Safety

Full Information

First Posted
July 28, 2011
Last Updated
July 26, 2017
Sponsor
Epidemiological and Clinical Research Information Network
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1. Study Identification

Unique Protocol Identification Number
NCT01406249
Brief Title
XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer
Official Title
A Randomized Phase II Trial Comparing Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer (XParTS II)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epidemiological and Clinical Research Information Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to elucidate the efficacy and safety of XP and SP for first-line treatment of Advanced Gastric Cancer.
Detailed Description
XP and SP are either standard treatment for advanced gastric cancer. The aim of this study is to elucidate the efficacy and safety of Capecitabine/Cisplatin and S-1/Cisplatin for first-line treatment of Advanced Gastric Cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
unresectable gastric cancer, recurrent gastric cancer, StageIV gastric cancer, adenocarcinoma of the stomach, XP, SP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S-1,Cisplatin
Arm Type
Active Comparator
Arm Title
Capecitabine, Cisplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SP
Intervention Description
Drug: S-1: S-1 will be administered at 40 mg/m2 orally, twice daily (80 mg/m2 total daily dose) on Days 1 through 21 of each 35-day treatment cycle. Drug: Cisplatin: Cisplatin will be administered at 60 mg/m2 by intravenous infusion on Day 8 of each 35-day treatment cycle.
Intervention Type
Drug
Intervention Name(s)
XP
Intervention Description
Drug: Capecitabine: Capecitabine will be administered at 1,000 mg/m2 orally, twice daily (2,000 mg/m2 total daily dose) on Days 1 through 14 of each 21-day treatment cycle. Drug: Cisplatin: Cisplatin will be administered at 80 mg/m2 by intravenous infusion on Day 1 of each 21-day treatment cycle.
Primary Outcome Measure Information:
Title
Progression-free survival rate
Time Frame
at 24weeks from patient enrollment
Secondary Outcome Measure Information:
Title
Time-to treatment failure
Time Frame
3year
Title
Response rate
Time Frame
3 year
Title
Overall survival
Time Frame
3 year
Title
Safety
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1) No previous chemotherapy or radiotherapy. However, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy ECOG Performance Status of 0 to 2 Life expectancy of at least 3 months after registration Written informed consent Age of 20 to 74 years with either gender Adequate Major organ functions within 14 days before registration Exclusion Criteria: Positive HER2 status Previous history of fluoropyrimidines therapy within 6 months prior to registration Previous treatment with platinum agents Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency 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. Obvious infection or inflammation (pyrexia ≥ 38.0˚C) Active hepatitis Heart disease that is serious or requires hospitalization, or history of such disease within past year Having complication 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) Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium Chronic diarrhea (watery stool or ≥4 times/day) Active gastrointestinal bleeding Body cavity fluids requiring drainage or other treatment Clinical suspicion or previous history of metastasis to brain or meninges Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant Unwillingness to practice contraception Poor oral intake Psychiatric disorders which are being or may need to be treated with psychotropics Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akira Tsuburaya
Organizational Affiliation
Shonan Kamakura Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Epidemiological and Clinical Research Information Network
City
Kyoto
ZIP/Postal Code
606-8392
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22824079
Citation
Tsuburaya A, Morita S, Kodera Y, Kobayashi M, Shitara K, Yamaguchi K, Yoshikawa T, Yoshida K, Yoshino S, Sakamoto J. A randomized phase II trial to elucidate the efficacy of capecitabine plus cisplatin (XP) and S-1 plus cisplatin (SP) as a first-line treatment for advanced gastric cancer: XP ascertainment vs. SP randomized PII trial (XParTS II). BMC Cancer. 2012 Jul 23;12:307. doi: 10.1186/1471-2407-12-307.
Results Reference
derived

Learn more about this trial

XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer

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