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

July 26, 2017 updated by: Epidemiological and Clinical Research Information Network

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 606-8392
        • Epidemiological and Clinical Research Information Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 74 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Capecitabine, Cisplatin
Drug: Capecitabine, Cisplatin

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 2 year
2 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 year
2 year
Response rate
Time Frame: 2 year
2 year
Time to treatment failure
Time Frame: 2 year
2 year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 2 year
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epidemiological and Clinical Research Information Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

July 30, 2011

First Submitted That Met QC Criteria

August 8, 2011

First Posted (ESTIMATE)

August 9, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECRIN-GC1106-XParTS
  • UMIN000005857 (OTHER: UMIN Clinical Trials Registry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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