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XParTS: Capecitabine/Cisplatin(XP) for Recurrent Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Capecitabine, Cisplatin
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 gastric cancer, recurrent gastric cancer, adenocarcinoma of the stomach, capecitabine, xp

Eligibility Criteria

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

Inclusion Criteria:

  1. Recurrent gastric cancer histologically confirmed as being adenocarcinoma
  2. Age of 20 to 74 years with either gender
  3. ECOG Performance Status of 0 to 2
  4. Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1)
  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. In case with receiving neoadjuvant chemotherapy, the total dose of CDDP does not exceed 120mg/m2
  8. Treatment-naïve recurrent gastric cancer
  9. Life expectancy of at least 3 months after registration
  10. Written informed consent

  11. Adequate major organ functions within 14 days before registration

    Exclusion Criteria:

  12. Positive HER2 status
  13. Previous treatment with platinum agents after curative surgery
  14. Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents
  15. Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency
  16. 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.
  17. Obvious infection or inflammation (pyrexia ≥ 38.0˚C)
  18. Active hepatitis
  19. 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 diarrhea (watery stool or ≥ 4 times/day)

12) Active gastrointestinal hemorrhage

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

Sites / Locations

  • Epidemiological and Clinical Research Information Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capecitabine, Cisplatin

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival
Response rate
Time to treatment failure
Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Full Information

First Posted
July 30, 2011
Last Updated
July 26, 2017
Sponsor
Epidemiological and Clinical Research Information Network
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1. Study Identification

Unique Protocol Identification Number
NCT01412294
Brief Title
XParTS: Capecitabine/Cisplatin(XP) for Recurrent Gastric Cancer
Official 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 (XParTS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 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 evaluate efficacy and safety of Capecitabine/Cisplatin for gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.
Detailed Description
S-1/Cisplatin (SP) is one of the standard treatments of advanced gastric cancer. However, evidence of SP on gastric cancer recurrence after adjuvant therapy by the same drug (S-1) is not established. The aim of this study is to evaluate the efficacy and safety of Capecitabine/Cisplatin (XP) for gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, recurrent gastric cancer, adenocarcinoma of the stomach, capecitabine, xp

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Capecitabine, Cisplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Capecitabine, Cisplatin
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
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
2 year
Title
Response rate
Time Frame
2 year
Title
Time to treatment failure
Time Frame
2 year
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Weeks
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Recurrent gastric cancer histologically confirmed as being adenocarcinoma Age of 20 to 74 years with either gender ECOG Performance Status of 0 to 2 Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1) Post-gastrectomy adjuvant chemotherapy including S-1 for at least 12 weeks including interruption period Less than 6 months treatment-free interval from completion of adjuvant therapy In case with receiving neoadjuvant chemotherapy, the total dose of CDDP does not exceed 120mg/m2 Treatment-naïve recurrent gastric cancer Life expectancy of at least 3 months after registration Written informed consent Adequate major organ functions within 14 days before registration Exclusion Criteria: Positive HER2 status Previous treatment with platinum agents after curative surgery 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 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 diarrhea (watery stool or ≥ 4 times/day) 12) Active gastrointestinal hemorrhage 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
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
29488122
Citation
Nishikawa K, Tsuburaya A, Yoshikawa T, Takahashi M, Tanabe K, Yamaguchi K, Yoshino S, Namikawa T, Aoyama T, Rino Y, Kawada J, Tsuji A, Taira K, Kimura Y, Kodera Y, Hirashima Y, Yabusaki H, Hirabayashi N, Fujitani K, Miyashita Y, Morita S, Sakamoto J. A phase II trial of capecitabine plus cisplatin (XP) for patients with advanced gastric cancer with early relapse after S-1 adjuvant therapy: XParTS-I trial. Gastric Cancer. 2018 Sep;21(5):811-818. doi: 10.1007/s10120-018-0815-0. Epub 2018 Feb 27.
Results Reference
derived

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XParTS: Capecitabine/Cisplatin(XP) for Recurrent Gastric Cancer

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