NCT00028002

Brief Summary

Phase II trial to study the effectiveness of neoadjuvant and adjuvant imatinib mesylate in treating patients who are undergoing surgery for primary or recurrent malignant gastrointestinal stromal tumor. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving imatinib mesylate before and after surgery may shrink the tumor so it can be removed and may kill any tumor cells remaining after surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2001

Completed
4 months until next milestone

Study Start

First participant enrolled

March 31, 2002

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2009

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

July 10, 2013

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

6.8 years

First QC Date

December 7, 2001

Results QC Date

November 29, 2012

Last Update Submit

October 22, 2020

Conditions

Gastrointestinal Stromal Tumor

Outcome Measures

Primary Outcomes (1)

  • Rate of Disease Progression at 2 Years

    Kaplan-Meier estimate of disease progression rate. Disease progression is determined by Response Evaluation Criteria in Solid Tumours criteria (RECIST). RECIST criteria is described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist\_guideline.pdf

    From registration to two years

Secondary Outcomes (3)

  • Rates of Objective Response (Complete, Partial, and Stable)

    Pretreatment and prior to surgery (at 4-10 weeks, based on surgery timing)

  • Percentage of Patients With Major Toxicity (Toxicity Grade ≥ 3)

    Analysis occurs after all patients have been on study for at least 2 years. Measured from start of treatment to end of follow-up, to a maximum of 4.95 years.

  • FDG-PET as Biological Marker of Metabolic Response(MR) During Imatinib Mesylate (IM) Treatment, in Patients With GIST Who Are naı¨ve to Tyrosine Kinase Inhibitor Therapy

    change from baseline to 1 week post therapy

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.

Procedure: Conventional SurgeryDrug: Imatinib Mesylate

Interventions

Conventional SurgeryPROCEDURE

Undergo surgical resection

Arm I
Imatinib MesylateDRUG

Given orally

Also known as: CGP 57148, CGP57148B, Gleevec, Glivec, STI 571, STI-571, STI571
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed malignant gastrointestinal stromal tumor
  • Potentially resectable primary disease
  • Potentially resectable recurrent disease
  • Local or intra-abdominal/pelvic metastatic disease
  • Documented c-kit (CD117) expression by immunohistochemical analysis of either initial core specimen or, if recurrent disease, from original tumor block
  • Primary disease must be visceral, intra-abdominal, or pelvic in origin
  • At least 1 unidimensionally measurable lesion
  • At least 5 cm for primary disease
  • At least 2 cm for recurrent disease
  • At least 1 viable core biopsy tumor specimen obtained within 8 weeks before registration
  • Performance status - Zubrod 0-2
  • WBC at least 3,000/mm\^3
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiation Therapy Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (3)

  • Van den Abbeele AD, Gatsonis C, de Vries DJ, Melenevsky Y, Szot-Barnes A, Yap JT, Godwin AK, Rink L, Huang M, Blevins M, Sicks J, Eisenberg B, Siegel BA. ACRIN 6665/RTOG 0132 phase II trial of neoadjuvant imatinib mesylate for operable malignant gastrointestinal stromal tumor: monitoring with 18F-FDG PET and correlation with genotype and GLUT4 expression. J Nucl Med. 2012 Apr;53(4):567-74. doi: 10.2967/jnumed.111.094425. Epub 2012 Mar 1.

    PMID: 22381410RESULT

  • 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.

    PMID: 18942073RESULT

  • Wang D, Zhang Q, Blanke CD, Demetri GD, Heinrich MC, Watson JC, Hoffman JP, Okuno S, Kane JM, von Mehren M, Eisenberg BL. Phase II trial of neoadjuvant/adjuvant imatinib mesylate for advanced primary and metastatic/recurrent operable gastrointestinal stromal tumors: long-term follow-up results of Radiation Therapy Oncology Group 0132. Ann Surg Oncol. 2012 Apr;19(4):1074-80. doi: 10.1245/s10434-011-2190-5. Epub 2011 Dec 28.

    PMID: 22203182RESULT

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Results Point of Contact

Title
Wendy Seiferheld
Organization
Radiation Therapy Oncology Group
wseiferheld@acr.org

Study Officials

  • Burton Eisenberg

    Radiation Therapy Oncology Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2001

First Posted

January 27, 2003

Study Start

March 31, 2002

Primary Completion

January 28, 2009

Study Completion

January 28, 2009

Last Updated

October 26, 2020

Results First Posted

July 10, 2013

Record last verified: 2020-10

Locations

US(1)