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Gastric CancerPhase 2NCT00134095

S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer

A Phase 2 study testing irinotecan hydrochloride, tegafur-gimeracil-oteracil potassium and adjuvant therapy in people with Gastric Cancer, run by Fukushima Medical University Hospital at 7 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

RATIONALE: Drugs used in chemotherapy, such as S-1 and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
irinotecan hydrochloride, tegafur-gimeracil-oteracil potassium and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
70 participants
Where
7 sitesJapan
Study dates
Sep 2004to Aug 2008
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed gastric adenocarcinoma
  • Locally advanced disease
  • Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)
  • Planning to undergo curative surgery after neoadjuvant chemotherapy

PATIENT CHARACTERISTICS:

Age

  • 20 to 75

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC 4,000-12,000/mm^3
  • Granulocyte count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL

Hepatic

  • AST and ALT ≤ 100 U/L
  • Bilirubin ≤ 1.5 mg/dL

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 50 mL/min

Pulmonary

  • PaO_2 > 60 mm Hg on room air

Other

  • Able to swallow oral medication

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for gastric cancer

Chemotherapy

  • No prior chemotherapy for gastric cancer

Endocrine therapy

  • No prior endocrine therapy for gastric cancer

Radiotherapy

  • No prior radiotherapy for gastric cancer

Surgery

  • No prior surgery for gastric cancer

Other

  • No other prior therapy for gastric cancer

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Japan7 sites

  • Asahikawa Kosei General Hospital

    Asahikawa, Hokkaido, 078-8211

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • Kobe City General Hospital

    Kobe, Hyōgo, 650

  • Iwate Medical University Hospital

    Morioka, Iwate, 020-8505

  • Yamamoto Kumiai General Hospital

    Noshiro, Akita, 016-0014

  • Tsuruoka Municipal Shonai Hospital

    Tsuruoka, Yamagata, 997-8515

  • Yamagata Prefectural Central Hospital

    Yamagata, Yamagata, 990-2292

Other trials in Japan

About this study

Official title: Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer

RATIONALE: Drugs used in chemotherapy, such as S-1 and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may shrink the tumor so that it can be completely removed.

PURPOSE: This phase II trial is studying how well giving S-1 together with irinotecan works in treating patients who are undergoing surgery for locally advanced stomach cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the efficacy of neoadjuvant S-1 and irinotecan in patients with locally advanced gastric cancer.

Secondary

  • Determine the histological response in patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.
  • Determine the progression-free survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine postoperative morbidity in patients treated with this regimen.
  • Determine the rate of potentially curative surgery in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral S-1 on days 1-21 and irinotecan IV over 90 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. After surgery, patients resume treatment with S-1 alone as before for 1 year.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Conditions
Gastric Cancer
Being tested
irinotecan hydrochloride, tegafur-gimeracil-oteracil potassium, adjuvant therapy, conventional surgery, neoadjuvant therapy
Keywords
adenocarcinoma of the stomach, stage II gastric cancer, stage III gastric cancer, stage IV 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.

What is being measured

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

  1. Tumor shrinkage

  2. Historical tumor shrinkage

  3. Overall survival

  4. Progression-free survival

  5. Median survival

  6. Safety

Timeline

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

  1. First posted24 Aug 2005 (estimated)
  2. Study startSep 2004
  3. Primary 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 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00134095
Sponsor's protocol ID
CDR0000439474
Other IDs
FMUH-UHA-GC04-02
Status last verified
Jan 2010
First submitted
22 Aug 2005
Last updated
17 Sep 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing irinotecan hydrochloride, tegafur-gimeracil-oteracil potassium and adjuvant therapy in people with Gastric Cancer, run by Fukushima Medical University Hospital at 7 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?

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 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 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?

Tumor shrinkage. The study lists 6 primary outcomes in all. 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 NCT00134095.

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 17 Sep 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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