SWOG clinical trial number
S0033

"Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)"

Closed
Phase
Accrual
100%
Published
Abbreviated Title
Gastrointestinal Stromal Tumor
Activated
12/15/2000
Closed
09/01/2001
Participants
NCORP, Members, Medical Oncologists, Surgeons, Pathologists, ECOG, CALGB, NCIC-CTG

Research committees

Sarcoma

Treatment

STI-571/Imatinib

Eligibility Criteria Expand/Collapse

Pathology

Pts must have biopsy proven dx of GIST that is unresectable or distantly metastatic. The primary must be of visceral or intraabdominal origin. Pts must have IHC documentation of KIT (CD117) expression by DAKO. Pts. must have measurable or non-measurable dz by conventional scan imaging or physical exam documented 28 days prior to registration. Pts must not have known brain mets. Zubrod PS 0-3. No prior chemo, biologic or other investigational tx for any reason within 28 days. No prior or concomitant RT except palliative RT. Prior surgery is allowed if at least 14 days have elapsed. No Class 3/4 cardiac problems, no severe or uncontrolled concurrent dz. Pts must not be taking therapeutic doses of coumadin. Women of reproductive potential must have a negative serum pregnancy test w/in 7 days.

Publication Information Expand/Collapse

2018

Survival by Hispanic Ethnicity among Cancer Patients Participating in SWOG Clinical Trials

M Chavez-MacGregor;J Unger;A Moseley;S Ramsey;DL Hershman Cancer Apr 15;124(8):1760-1769; Jan 25 [Epub ahead of print]

PMid: PMID29370458 | PMC number: PMC5963502

Survival by Hispanic Ethnicity Among Cancer Patients participating in SWOG Clinical Trials

A Moseley;M Chavez-MacGregor;J Unger;S Ramsey;D Hershman Society for Clinical Trials Annual Meeting (May 20-23 2018, Portland, OR), oral presentation

2017

Association between body mass index and cancer survival in a pooled analysis of 22 clinical trials

H Greenlee;J Unger;M Leblanc;S Ramsey;D Hershman Cancer Epidemiology Biomarkers & Prevention 2017 Jan;26(1):21-29; 2016 Dec 16. [Epub ahead of print]

PMid: PMID27986655 | PMC number: PMC5370550

Long-term results of imatinib mesylate in advanced gastrointestinal stromal tumors (GIST) correlated with next generation sequencing results: SWOG phase III intergroup trial S0033

M Heinrich;C Rankin;CD Blanke;G Demetri;E Borden;C Ryan;M von Mehren;M Blackstein;D Priebat;W Tap;R Maki;C Corless;JA Fletcher;K Owzar;J Crowley;R Benjamin;LH Baker JAMA Oncology Jul 1;3(7):944-952; 2017 Feb 9 [Epub ahead of print]

PMid: PMID28196207; PMC5727908

2014

Long-term disease control of advanced gastrointestinal stromal tumors (GIST) with imatinib (IM): 10-year outcomes from SWOG phase III intergroup trial S0033

G Demetri;C Rankin;R Benjamin;E Borden;CW Ryan;D Priebat;WD Tap;M von Mehren;ME Blackstein;M Heinrich;R Maki;C Corless;JA Fletcher;K Owzar;CD Blanke Journal of Clinical Oncology 32:5s (suppl; abstr 10508);ASCO Annual Meeting (May 30-June 3, 2014, Chicago, IL), oral;

Association between BMI at treatment initiation and cancer survival across multiple SWOG trials

H Greenlee;J Unger;M Leblanc;D Hershman AACR Research International Conference on Frontiers on Cancer Research Prevention (Sept 28-Oct 1, 2014, New Orleans, LA; poster

2011

Long-term follow-up of SWOG S0033, a phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST)

L Baker;C Rankin;C Blanke;G Demetri;J Crowley;R Benjamin;J Stevenson;M Blackstein;D Priebat;W Tap;M Von Mehren Connective Tissue Oncology Society Annual Meeting , oral

Long-term survival on S0033: a phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors (GISTs)

C Blanke;C Rankin;R Benjamin;AK Raymond;M Heinrich;C Fletcher;J Crowley;EC Borden;G Demetri;L Baker European Society for Medical Oncology Annual Meeting, oral;

2010

Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors: a meta-analysis of 1,640 patients [PMC2834472; PMID20124181]

M. Van Glabbeke;J. Verweij;J-Y. Blay;M. Debiec-Rychter;G.D. Demetri;M.C. Heinrich;E.C. Borden;B.G. Redman;C.D. Blanke;C. Rankin;J.J. Crowley;P. Casali;M. von Mehren;C. Fletcher;J. Fletcher;K. Owzar;J. Zalcberg;J. Simes;V. Bramwell-Wesley Journal of Clinical Oncology 28(7):1247-1253;

2008

Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033 [PMID18235122]

CD Blanke;C Rankin;GD Demetri;CW Ryan;M von Mehren;RS Benjamin;AK Raymond;VH Bramwell;LH Baker;RG Maki;JR Hecht;MC Heinrich;CD Fletcher;JJ Crowley;EC Borden Journal of Clinical Oncology 26(4):626-632

The Southwest Oncology Group: progress in cancer research [PMID18929152]

CA Coltman Seminars in Oncology 35(5):545-552

Correlation of kinase genotype and clinical outcome in the North American Intergroup phase III trial of imatinib mesylate for treatment of advanced gastrointestinal stromal tumor: CALGB 150105 study by Cancer and Leukemia Group B and Southwest Oncology Group [PMC2651078; PMID18955451]

MC Heinrich;K Owzar;CL Corless;D Holllis;EC Borden;CD Fletcher;CW Ryan;M von Mehren;CD Blanke;C Rankin;RS Benjamin;VH Bramwell;GD Demetri;MM Bertagnolli;JA Fletcher Journal of Clinical Oncology 26(33):5360-5357

2007

Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors (GIST): a meta-analysis based on 1,640 patients (pts).

MM Van Glabbeke;K Owzar;C Rankin;J Simes;J Crowley Proc of the American Society of Clinical Oncology, Journal of Clinical Oncology 25(18S):#10004

2005

Clinical benefit of Imatinib in patients (pts) with metastatic gastrointestinal stromal tumors (GIST) negative for the expression of CD117 in the S0033 trial.

ME Blackstein;C Rankin;C Fletcher;M Heinrich;R Benjamin;M von Mehren;C Blanke;JA Fletcher;E Borden;G Demetri Proc of the ASCO, JCO 23(16S):818s (#9010)

Incidence and reasons for dose modification of standard-dose vs. high-dose imatinib mesylate (IM) in the phase III intergroup study S0033 of patients (pts) with unresectable or metastatic gastrointestinal stromal tumor (GIST)

P Dileo;CJ Rankin;RS Benjamin;M von Mehren;C Blanke;V Bramwell;R Maki;C Fletcher;EC Borden;GD Demetri Proc of the ASCO, JCO 23(16S):824s (#9032)

Correlation of target kinase genotype with clinical activity of imatinib mesylate (IM) in patients with matastatic GI Stromal tumors (GISTs) expressing KIT (KIT+)

MC Heinrich;JS Shoemaker;CL Corless;D Hollis;GD Demetri;MM Bertagnolli;JA Fletcher Proc of the ASCO, JCO 23(16S):3s (#7)

2004

Dose effect of imatinib (IM) in patients (pts) with metastatic GIST-phase III sarcoma group study S0033

C Rankin;M von Mehren;C Blanke;R Benjamin;CDM Fletcher;V Bramwell;J Crowley;GD Demetri Proc of the American Society of Clinical Oncology 23:815 (#9005)

2003

Phase III dose-randomized study of imatinib mesylate (STI571) for GIST: Intergroup S0033 early results.

RS Benjamin;C Rankin;C Fletcher;C Blanke;M Von Mehren;R Maki;V Bramwell;L Baker;E Borden;GD Demetri Proc of the American Society of Clinical Oncology 22:814(#3271)

Correlation of computerized tomography (CT) and proton emission tomography (PET) in patients with metastatic GIST treated at a single institution with imatinib mesylate

H Choi;C Charnsangavej;HA Macapinlac;MA Burgess;SR Patel;LL Chen;DA Podoloff;RS Benjamin Proc of the American Society of Clinical Oncology 22:819(#3290)

2002

Phase III dose-randomized study of Imatinib mesylate (Gleevec, STI571) for GIST: Intergroup S0033 early results

GD Demetri;C Rankin;C Fletcher;R Benjamin;C Blanke;M Von Mehren;V Bramwell;R Maki;R Blum;K Antman;L Baker;E Borden Proc of the American Society of Clinical Oncology 21:413a(#1651)

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