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Gastric CancerPhase 2NCT01406249

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

A Phase 2 study testing SP and XP in people with Gastric Cancer, run by Epidemiological and Clinical Research Information Network at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Gastric Cancer
What is being tested?
SP and XP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteJapan
Study dates
Aug 2011to Dec 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Epidemiological and Clinical Research Information Network

    Kyoto, 606-8392

Other trials in Japan

About this study

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)

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

Read the 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.

Conditions
Gastric Cancer
Being tested
SP, XP
Keywords
unresectable gastric cancer, recurrent gastric cancer, StageIV gastric cancer, adenocarcinoma of the stomach, XP, SP
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPDrug

    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.

  • XPDrug

    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.

Study groups in NCT01406249
Study groupRoleWhat they receive
S-1,CisplatinActive comparatorNot described
Receives: Drug: SP
Capecitabine, CisplatinExperimentalNot described
Receives: Drug: XP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival rate

    Measured: at 24weeks from patient enrollment

Secondary outcomes (4)

  1. Time-to treatment failure

    Measured: 3year

  2. Response rate

    Measured: 3 year

  3. Overall survival

    Measured: 3 year

  4. Safety

    Measured: 3 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01406249
Sponsor's protocol ID
ECRIN-GC1107-XParTS II
Other IDs
UMIN000006045
Status last verified
Jul 2017
First submitted
28 Jul 2011
Last updated
27 Jul 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22824079

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SP and XP in people with Gastric Cancer, run by Epidemiological and Clinical Research Information Network at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival rate (time frame: at 24weeks from patient enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01406249, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.

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