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Gastric CancerPhase 3NCT00195572

Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

A Phase 3 study testing Isovorin and TS-1 in people with Gastric Cancer, run by Wyeth is now a wholly owned subsidiary of Pfizer at 43 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to verify non-inferiority of survival time between Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable advanced or recurrent gastric cancer. Read more about this study

Who is it for?
Ages 20 to 77 years
Conditions the study is for
Gastric Cancer
What is being tested?
Isovorin and TS-1
How many people
200 participants
Where
43 sitesJapan
Study dates
May 2002to Aug 2008
Phase
Phase 3
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 77 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Gastric cancer diagnosed histologically or cytologically
  • Normal organ function of bone marrow, heart, liver and kidney
  • Age of 20-77
  • Other inclusion applies

Who cannot join

  • Serious infection, heart disease, complication or organ disorder
  • Ongoing administration of flucytosine
  • Pregnant or breastfeeding women
  • Other exclusion applies

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

Japan43 sites

  • Study site

    Adachi-ku, Tokyo, 123-0855

  • Study site

    Anjo, 446-8602

  • Study site

    Aomori, 030-8553

  • Study site

    Chiba, 260-8607

  • Study site

    Chiba, 260-8717

  • Study site

    Chikushino-shi, 818-8502

  • Study site

    Fukuoka, 812-8582

  • Study site

    Fukuroi-shi, 437-0061

  • Study site

    Funai-gun, 629-0392

  • Study site

    Hiroshima, 730-8619

  • Study site

    Hiroshima, 734-8551

  • Study site

    Ichihara-shi, 290-0003

  • Study site

    Kanagawa, 224-8503

  • Study site

    Kanazawa, 920-8641

  • Study site

    Kisaradu-shi, 292-8535

  • Study site

    Kitaadachi-gun, 362-0806

  • Study site

    Koto-ku, Tokyo, 135-8577

  • Study site

    Kyoto, 602-8566

  • Study site

    Misawa-shi, 033-0001

  • Study site

    Morioka, 020-8505

  • Study site

    Nagasaki, 852-8501

  • Study site

    Nagoya, 458-0037

  • Study site

    Nagoya, 464-8681

  • Study site

    Ōmura, 856-8562

  • Study site

    Osaka, 537-8511

  • Study site

    Osaka, 545-8585

  • Study site

    Saga, 840-8571

  • Study site

    Sagamiharashi, 228-8520

  • Study site

    Sapparo City, 064-0923

  • Study site

    Sapporo, 003-8585

  • Study site

    Sapporo, 060-0001

  • Study site

    Sapporo, 060-8543

  • Study site

    Sasebo-shi, 857-8511

  • Study site

    Sendai, 983-8512

  • Study site

    Sendai, 983-8520

  • Study site

    Shizuka, 432-8580

  • Study site

    Shizuoka, 420-8527

  • Study site

    Sizuoka-shi, 420-8623

  • Study site

    Takatuki-si, 569-8666

  • Study site

    Tsuchiura-shi, 300-0053

  • Study site

    Tsukuba, 305-8576

  • Study site

    Uji-shi, 611-0042

  • Study site

    Yamagata, 990-2292

Other trials in Japan

About this study

Official title: Post-Approved Phase III Study of 1-LV/5FU Therapy

The purpose of the study is to verify non-inferiority of survival time between Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable advanced or recurrent gastric cancer. Secondary endpoints include response rates, duration of responses, time to progression (TTP) safety and quality of life (QOL).

Conditions
Gastric Cancer
Being tested
Isovorin, TS-1
Keywords
Gastric Cancer, Advanced/Recurrent Gastric Cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • IsovorinDrug

  • TS-1Drug

What is being measured

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

  1. Survival time

Secondary outcomes (1)

  1. Response rate, duration of response, time to progression, safety, quality of life

Timeline

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

  1. First posted19 Sep 2005 (estimated)
  2. Study startMay 2002
  3. Primary completionAug 2008
  4. Study completionAug 2008

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00195572
Sponsor's protocol ID
ISO/5FU-10
Status last verified
Aug 2009
First submitted
12 Sep 2005
Last updated
13 Aug 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Isovorin and TS-1 in people with Gastric Cancer, run by Wyeth is now a wholly owned subsidiary of Pfizer at 43 sites 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 13 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Survival time. 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 NCT00195572.

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 13 Aug 2009.

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