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

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

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)

The aim of this study is to elucidate the efficacy and safety of XP and SP for first-line treatment of Advanced Gastric Cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

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

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: S-1,Cisplatin
Drug: SP

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.
Experimental: Capecitabine, Cisplatin
Drug: XP

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 rate
Time Frame: at 24weeks from patient enrollment
at 24weeks from patient enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 year
3 year
Time-to treatment failure
Time Frame: 3year
3year
Response rate
Time Frame: 3 year
3 year
Safety
Time Frame: 3 year
3 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

August 1, 2011

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

July 29, 2011

First Posted (Estimate)

August 1, 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-GC1107-XParTS II
  • UMIN000006045 (Other Identifier: 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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