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AzTrials

Gastrointestinal Stromal TumorPhase 2GISTsNCT00769782

Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor

A Phase 2 study testing therapeutic conventional surgery in people with Gastrointestinal Stromal Tumor and Metastatic Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 37 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

RATIONALE: Surgery may be an effective treatment for liver metastasis from a gastrointestinal stromal tumor. PURPOSE: This phase II trial is studying how well surgery works in treating patients with liver metastasis from a gastrointestinal stromal tumor. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
therapeutic conventional surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
37 sitesJapan
Study dates
Oct 2008to Mar 2016
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of gastrointestinal stromal tumor (GIST)
  • Hepatic metastasis meeting the following criteria:
  • Clinically diagnosed as surgically resectable with no macroscopic residual tumor
  • No more than 3 hepatic metastases
  • Synchronous hepatic metastasis allowed provided primary tumor is also resectable
  • Does not require radiofrequency ablation and/or microwave coagulation therapy to control the disease
  • No extrahepatic metastasis
  • No history of GIST recurrence

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Leukocyte count ≥ 3,000/μL
  • Neutrophil count ≥ 1,500/μL
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 75,000/μL
  • Total bilirubin ≤ 2.0 mg/dL
  • ALT and AST < 120 IU/L
  • GTP < 210 IU/L
  • Not pregnant
  • No poorly controlled diabetes mellitus
  • No NYHA class III-IV cardiac function
  • No hepatitis B or hepatitis B carriers
  • No other malignancy requiring treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior interventional radiology for metastatic disease
  • No prior or concurrent imatinib mesylate
  • No other concurrent treatment

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

Japan37 sites

  • University of Yamanashi Hospital

    Chūō, Yamanashi, 409-3898

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Hamamatsu University School of Medicine

    Hamamatsu, Shizuoka, 431-3192

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 350-1241

  • Hirosaki University, School of Medicine

    Hirosaki, Aomori, 036-8562

  • Niigata Prefectural Central Hospital

    Jōetsu, Niigata, 943-0192

  • Kagoshima University

    Kagoshima, 890-8520

  • Kyoto Second Red Cross Hospital

    Kanigyou-ku, Kyoto, 602-8026

  • Kimitsu Chuo Hospital

    Kisarazu, 292-8535

  • University of Miyazaki Hospital

    Kiyotake, Miyazaki, 889-1692

  • Kochi Health Sciences Center

    Kochi, 781-8555

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kawasaki Medical School

    Kurashiki, Okayama-ken, 701-01

  • National Hospital Organization Kure Medical Center

    Kure, Hiroshima, 737-0023

  • Iwate Medical University Hospital

    Morioka, Iwate, 020-8505

  • Nagaoka Chuo General Hospital

    Nagaoka, Niigata, 940-8653

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

  • Aichi Medical University

    Nagoya, Aichi-ken, 480-1195

  • Kochi Medical School

    Nankoku, Kochi, 783-8505

  • Niigata University Medical and Dental Hospital

    Niigata, 951-8510

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Ryukyu University Hospital

    Nishiharacho, Okinawa, 903-0215

  • Okayama University Hospital

    Okayama, 700-8558

  • Sakai Municipal Hospital

    Sakai, Osaka, 590-0064

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Juntendo University Shizuoka Hospital

    Shizuoka, 410-2295

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • Osaka University Hospital

    Suita, Osaka, 565-0871

  • Tokushima University Hospital

    Tokushima, 770-8503

  • Tokyo Metropolitan - Komagome Hospital

    Tokyo, 113-0021

  • Keio University Hospital

    Tokyo, 160-8582

  • Toyama University Hospital

    Toyama, 930-0194

  • Toyonaka Municipal Hospital

    Toyonaka, Osaka, 560-8565

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-0815

  • International Goodwill Hospital

    Yokohama, Kanagawa, 245-0006

Other trials in Japan

About this study

Official title: Phase II Multicenter Clinical Trial on Surgery for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)

RATIONALE: Surgery may be an effective treatment for liver metastasis from a gastrointestinal stromal tumor.

PURPOSE: This phase II trial is studying how well surgery works in treating patients with liver metastasis from a gastrointestinal stromal tumor.

Read the detailed description

OBJECTIVES:

  • To evaluate the safety and efficacy of surgery in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor.

OUTLINE: This is a multicenter study.

Patients undergo surgical resection of hepatic metastasis.

Keywords
gastrointestinal stromal tumor, liver metastases
Medical subject headings
Gastrointestinal Stromal Tumors, Neoplasm Metastasis

What participants receive

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

  • therapeutic conventional surgeryProcedure or surgery

    All patients undergo suegery to achieve macroscopic complete resection within 28 days after enrollment (including enrollment day). As long as tumor free margin is ensured, all resection margin distances and all surgical procedure are accepted. Surgical treatment in this study excludes the following, radiofrequency ablation (RFA) without resection of liver only or microwave coagulation therapy (MCT) only; for RFA or MCT is used as additional treatment under judgment of primary physician for new liver tumor which comfirmed during surgery in different parts of liver except portion scheduled for resection, RFA and MCT are included. After histological curative resection, patients are observed without treatment until comfirming recurrence. Patients with incomplete tumor removal are withdrawn from protcol treatment and receive imatinib treatment, 400 mg/day orally. For reccurrence is comfirmed, patients receive imatinib treatment, 400 mg/day orally.

Study groups in NCT00769782
Study groupRoleWhat they receive
therapeutic conventional surgeryExperimentalAll patients undergo suegery to achieve macroscopic complete resection within 28 days after enrollment (including enrollment day). As long as tumor free margin is ensured, all resection margin distances and all surgical procedure are accepted. Surgical treatment in this study excludes the following, radiofrequency ablation (RFA) without resection of liver only or microwave coagulation therapy (MCT) only; for RFA or MCT is used as additional treatment under judgment of primary physician for new liver tumor which comfirmed during surgery in different parts of liver except portion scheduled for resection, RFA and MCT are included. After histological curative resection, patients are observed without treatment until comfirming recurrence. Patients with incomplete tumor removal are withdrawn from protcol treatment and receive imatinib treatment, 400 mg/day orally. For reccurrence is comfirmed, patients receive imatinib treatment, 400 mg/day orally.
Receives: Procedure: therapeutic conventional surgery

What is being measured

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

  1. Recurrence-free survival

    Recurrence-free survival is defined as time from date of surgery until date of recurrence or death from any cause, whichever comes first.

    Measured: 7.5 years

Secondary outcomes (3)

  1. Overall survival

    Overall survival is defined as time from date of surgery until date of death from any cause.

    Measured: 7.5 years

  2. Histological curative resection

    Histological curative resection is defined as complete tumor removal which comfirmed by pathological assessment of resected tissue. For radiofrequency ablation (RFA) or microwave coagulation therapy (MCT) is used as additional treatment for the new liver tumor which confirmed during surgery in different parts of liver except the portion scheduled for resection, the case is regarded as incomplete resection (R1). For peritoneal metastasis is confirmed during surgery, the case is regarded as incomplete resection (R1) regardless of macroscopic complete resection.

    Measured: At surgery

  3. Types and severities of adverse events

    Types and severities of adverse events from date of starting protocol treatment until 30 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center.

    Measured: 7.5 years

Timeline

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

  1. First posted9 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionMar 2016
  4. Study completionMar 2016

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00769782
Sponsor's protocol ID
CDR0000615624
Other IDs
NIIGATAU-TRIGIST0804
Acronym
GISTs
Status last verified
Jul 2023
First submitted
8 Oct 2008
Last updated
21 Jul 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing therapeutic conventional surgery in people with Gastrointestinal Stromal Tumor and Metastatic Cancer, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 37 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: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 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?

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?

Recurrence-free survival (time frame: 7.5 years). 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 NCT00769782.

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 21 Jul 2023.

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