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A Trial for Surgical Treatment in Patients With Initially Locally Unresectable Advanced GIST Without Metastasis During Therapy With Imatinib

Phase 2
18 Years
Open (Enrolling)
Gastrointestinal Stromal Tumor

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Trial Information

A Trial for Surgical Treatment in Patients With Initially Locally Unresectable Advanced GIST Without Metastasis During Therapy With Imatinib

Primary Objective

- To observe the safety of imatinib compared with that of historical data for locally
unresectable advanced GIST without metastasis.

Secondary Objective

- Progression-free survival (PFS) in resected patients during follow up

- R0 resection rate

- objective response rate, tumor shrinkage rate

- Correlation of mutation status with response

- Correlation of PK with response

- Surgical morbidity and mortality and safety follow up

- Quality of life

- Overall survival (OS)

Inclusion Criteria

Inclusion Criteria

- Locally advanced unresectable GIST without metastasis at

- EC junction requiring total gastrectomy,

- Duodenum requiring Whipple operation;

- Large GIST requiring multiviceral resection;

- Rectum: requiring APR.

- Histologically documentation with positive immunostaining for KIT (CD117)

- Patient age ≥ 18 years old

- ECOG performance status 0 or 1

- Patient must have the following post-operative laboratory values confirmed within 14
days prior to registration:

- Creatinine ≤ 1.5 times the institution ULN (upper limit of normal)

- WBC ≥ 3,000/mm3

- Platelets ≥ 100,000/mm3

- Total Bilirubin ≤ 1.5 times the institution ULN. NOTE: Patients with elevated
bilirubin secondary to Gilbert's disease are eligible to participate in the

- AST ≤ 2.5 times the institution ULN

- ALT ≤ 2.5 times the institution ULN

- Female of childbearing potential must have negative serum pregnancy test. --
-NOTE: Post-menopausal women must be amenorrheic for at least 12 months to be
deemed not of reproductive potential.

- Patient is willing to sign informed consent.

Exclusion Criteria

- Patient has received post-operative chemotherapy.

- Patient has received post-operative radiation therapy.

- Patient has received post-operative investigational treatment.

- Patient has received prior therapy with imatinib, or any other molecular targeted or
biological therapy.

- Patient has had an active infection requiring antibiotics within 14 days prior to

- any prior malignancies for at least 5 years with potential evidence of recurrence
(except for effectively treated basal cell or squamous carcinoma of the skin,
carcinoma in-situ of the cervix that has been effectively treated by surgery alone,
or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by
surgery alone).

- Patient is deemed by their treating physician to be at risk for recurrence from prior
malignancies.New York Heart Association Class 3 or 4 cardiac diseases.

- Patient is taking full dose warfarin. NOTE: The use of mini-dose warfarin (1 mg
orally per day) for prevention of central line-associated deep venous thrombosis is

- Presence of severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled
diabetes, uncontrolled chronic renal disease, uncontrolled liver disease, including
chronic viral hepatitis judged at risk of reactivation, uncontrolled active
infection, such as HIV infection, etc.).

- Patient, if female and breastfeeding. NOTE: It is not known whether imatinib or its
metabolites are excreted in human milk.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

progression free survival

Outcome Description:

Evidence of measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with CT scan.

Outcome Time Frame:

five years

Safety Issue:


Principal Investigator

Chun-Nan Yeh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Chang Gung Memorial Hospital, Linkou, Taiwan.


Taiwan: Department of Health

Study ID:

Yeh CN001



Start Date:

April 2012

Completion Date:

December 2019

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • gastrointestinal stromal tumor
  • GIST
  • neoadjuvant
  • imatinib
  • Neoplasm Metastasis
  • Gastrointestinal Stromal Tumors