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Gastrointestinal Stromal TumorPhase 2NCT01267695

Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

A Phase 2 study testing imatinib mesylate and conventional surgery in people with Gastrointestinal Stromal Tumor, run by Peking University at 1 site in China.

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

Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Perioperative imatinib mesylate may shrink the tumor and may reduce the chance of relapse after surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Stromal Tumor
What is being tested?
imatinib mesylate and conventional surgery
How many people
20 participants
Where
1 siteChina
Study dates
May 2010to Oct 2014
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Criteria:

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed gastrointestinal stromal tumor
  • Locally advanced disease: tumour size >5 cm and mitotic count >5/HPF; tumour size >10 cm; mitotic count >10/HPF
  • Potentially resectable disease: Multivisceral resection may be necessary to get sufficient margins
  • Documented c-kit (CD117) expression by immunohistochemical analysis of either initial core specimen or, if recurrent disease, from original tumor block
  • At least 1 site of measurable disease
  • No known brain metastases
  • PATIENT CHARACTERISTICS:

Age:18 and over Performance status:ECOG 0-3 Life expectancy:Not specified

  • Platelet count > 100,000/mm3
  • Absolute neutrophil count > 1,500/mm3 Hepatic
  • AST and ALT < 2.5 times upper limits of normal (ULN) (5 times ULN if hepatic metastases are present)
  • Bilirubin < 1.5 times ULN
  • No chronic active hepatitis
  • No cirrhosis
  • No other chronic liver disease Renal
  • Creatinine < 1.5 times ULN
  • No chronic renal disease Cardiovascular
  • No New York Heart Association class III-IV cardiac disease
  • No congestive heart failure
  • No myocardial infarction within the past 6 months Immunology
  • No active uncontrolled infection
  • No known HIV positivity Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
  • Must be medically fit to undergo surgery
  • No other primary malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or a primary malignancy that is not currently clinically significant and does not require active intervention
  • No gastrointestinal obstruction or major bleeding episode requiring immediate surgical intervention
  • No uncontrolled diabetes
  • No other severe or uncontrolled medical disease
  • No significant history of noncompliance to medical regimens

PRIOR CONCURRENT THERAPY:

  • No concurrent anticancer biologic agents
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) unless disease is rapidly progressing
  • No concurrent anticancer chemotherapy
  • At least 28 days since prior radiotherapy
  • More than 2 weeks since prior major surgery except tumor biopsy Other
  • At least 28 days since prior investigational drugs
  • At least 28 days since prior imatinib mesylate
  • No concurrent therapeutic doses of warfarin
  • Concurrent low-molecular weight heparin or mini-dose warfarin (1 mg per day) prophylaxis is allowed

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University School of Oncology

    Beijing, 100142

Other trials in China

About this study

Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Perioperative imatinib mesylate may shrink the tumor and may reduce the chance of relapse after surgery. This phase II trial is studying the effectiveness of perioperative imatinib mesylate in treating patients with locally advanced gastrointestinal stromal tumor.

Read the detailed description

Open-label trial in patients with locally advanced GISTs admitted to Department of Surgery, Beijing Cancer Hospital and Institute between April 2010 and May 2013 was carried out prospectively. Patients were planned to be treated with imatinib for duration of 6 months followed by surgical resection. Postoperative imatinib was planned to be administrated for 1.5 years. The primary end point was recurrent free survival (RFS) at 2 years; the secondary end points included objective response rate (ORR), surgical outcomes and drug safety.

Being tested
imatinib mesylate, conventional surgery
Keywords
Gastrointestinal Stromal Tumor, Imatinib mesylate, Perioperative therapy
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

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

  • imatinib mesylateDrug

    Also called Gleevec, STI-571, NSC #716051

    Patients receive oral imatinib mesylate once daily for 6 months in the absence of disease progression or unacceptable toxicity. Patients with disease progression or unacceptable toxicity are considered for immediate surgical resection. Within 2-6 weeks after completion of imatinib mesylate, patients with responding or stable disease undergo surgical resection. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for one and a half years.

  • conventional surgeryProcedure or surgery

    All the patients should receive elective surgery with R0 resection.

What is being measured

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

  1. Rate of disease recurrence at 2 years

    Measured: 4 years

Secondary outcomes (2)

  1. Rates of objective response (complete, partial, and stable)

    Measured: 2 years

  2. Determine the safety and tolerability of this drug in these patients.

    Measured: 3 years

Timeline

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

  1. First posted28 Dec 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionOct 2014
  4. Study completionOct 2014

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01267695
Sponsor's protocol ID
WJP-320.6700.09010
Status last verified
Feb 2015
First submitted
27 Dec 2010
Last updated
3 Feb 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Eisenberg BL, Harris J, Blanke CD, Demetri GD, Heinrich MC, Watson JC, Hoffman JP, Okuno S, Kane JM, von Mehren M. Phase II trial of neoadjuvant/adjuvant imatinib mesylate (IM) for advanced primary and metastatic/recurrent operable gastrointestinal stromal tumor (GIST): early results of RTOG 0132/ACRIN 6665. J Surg Oncol. 2009 Jan 1;99(1):42-7. doi: 10.1002/jso.21160.

    PubMed 18942073

  • Seshadri RA, Rajendranath R. Neoadjuvant imatinib in locally advanced gastrointestinal stromal tumors. J Cancer Res Ther. 2009 Oct-Dec;5(4):267-71. doi: 10.4103/0973-1482.59905.

    PubMed 20160360

  • Saied GM, Kensarah AM. Six months neoadjuvant imatinib improves resectability potential of gastric stromal tumors in Egyptian patients. Int J Surg. 2010;8(2):105-8. doi: 10.1016/j.ijsu.2009.09.016. Epub 2009 Nov 24.

    PubMed 19944196

  • Machlenkin S, Pinsk I, Tulchinsky H, Ziv Y, Sayfan J, Duek D, Rabau M, Walfisch S. The effect of neoadjuvant Imatinib therapy on outcome and survival after rectal gastrointestinal stromal tumour. Colorectal Dis. 2011 Oct;13(10):1110-5. doi: 10.1111/j.1463-1318.2010.02442.x.

    PubMed 21040362

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imatinib mesylate and conventional surgery in people with Gastrointestinal Stromal Tumor, run by Peking University at 1 site in China.

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 3 Feb 2015. 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 China. 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?

Rate of disease recurrence at 2 years (time frame: 4 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 NCT01267695, which also lists 4 linked publications.

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 3 Feb 2015.

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