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Gastric CancerPhase 2NCT01412294

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

A Phase 2 study testing Capecitabine, Cisplatin 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 The sponsor has not verified this record for over two years, so it may be out of date.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 evaluate efficacy and safety of Capecitabine/Cisplatin for gastric cancer patients who relapsed after adjuvant chemotherapy by S-1. Read more about this study

Who is it for?
Ages 20 weeks to 74 years
Conditions the study is for
Gastric Cancer
What is being tested?
Capecitabine, Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteJapan
Study dates
Jul 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 weeks to 74 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

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: 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.

Read the 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.

Conditions
Gastric Cancer
Being tested
Capecitabine, Cisplatin
Keywords
gastric cancer, recurrent gastric cancer, adenocarcinoma of the stomach, capecitabine, xp
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Capecitabine, CisplatinDrug

    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 NCT01412294
Study groupRoleWhat they receive
Capecitabine, CisplatinExperimentalNot described
Receives: Drug: Capecitabine, Cisplatin

What is being measured

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

  1. Progression-free survival

    Measured: 2 year

Secondary outcomes (4)

  1. Overall survival

    Measured: 2 year

  2. Response rate

    Measured: 2 year

  3. Time to treatment failure

    Measured: 2 year

  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Measured: 2 year

Timeline

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

  1. First posted9 Aug 2011 (estimated)
  2. Study startJul 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01412294
Sponsor's protocol ID
ECRIN-GC1106-XParTS
Other IDs
UMIN000005857
Status last verified
Jul 2017
First submitted
30 Jul 2011
Last updated
27 Jul 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29488122

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine, Cisplatin 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 11 inclusion and 18 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 (time frame: 2 year). 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 NCT01412294, 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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