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Surgery for Locally Unresectable Advanced GISTs Without Metastasis After Imatinib Therapy

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ClinicalTrials.gov Identifier: NCT01865565
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Chun-Nan Yeh, Chang Gung Memorial Hospital

Brief Summary:
Gastrointestinal stromal tumors (GISTs) are a form of sarcoma and the most common sarcoma tumors of the gastrointestinal tract. The limited clinical experience suggests that GIST patients may benefit from neo-adjuvant therapy from primary GIST. This is a prospective, multicenter, open, observational study in evaluation of safety and efficacy of imatinib compared with that of historical data for locally unresectable advanced GIST without metastasis. The study will include an up to 28-day screening period, followed by receiving imatinib mesylate (400 mg/day) for at least 6-12 months and followed up for 3 years after surgery.

Condition or disease
Gastrointestinal Stromal Tumor

Detailed Description:

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)

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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Trial for Surgical Treatment in Patients With Initially Locally Unresectable Advanced GIST Without Metastasis During Therapy With Imatinib
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2017


Group/Cohort
Imatinib treat

• Locally advanced unresectable GIST without metastasis at

  • EC junction requiring total gastrectomy,
  • Duodenum requiring Whipple operation;
  • Large GIST requiring multiviceral resection;
  • Rectum: requiring APR.



Primary Outcome Measures :
  1. progression free survival [ Time Frame: five years ]
    Evidence of measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with CT scan.


Secondary Outcome Measures :
  1. R0 resection rate [ Time Frame: three years ]
    all the participants

  2. Objective response rate, tumor shrinkage rate [ Time Frame: three years ]
    all the participants

  3. Correlation of PK with response [ Time Frame: three years ]
    check PK (trough level of imatinib)of all the participants at first month and every three months later to correlate with the response and check PK (peak level of imatinib) of all the participants who had adverse events

  4. Surgical morbidity and mortality and safety follow up [ Time Frame: five years ]
    surgical morbidity: morbidity related to surgical procedure surgical mortality: mortality related to surgical procedure safety: adverse events related imatinib according to NIH toxicity evaluation criteria

  5. Overall survival (OS) [ Time Frame: five years ]
    Overall survival (OS) will be measured from after administration of imatinib mesylate and death as the end point of the study, whatever the cause. Alive patients will be censored at the date of last follow-up. Causes of death will be recorded.


Biospecimen Retention:   Samples With DNA
Histologically verified GIST and exon genotype.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will be conducted in four branch hospitals of Chang Gung Memorial Hospital, Taiwan including Keelung, Linkou, Cha-Yi, and Kaoshung, respectively. To target 50 patients; 90% patients with response after imatinib treatment; 10% patients without response; compare the result with historical data.
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 study.
    • 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 registration.
  • 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 permitted.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865565


Locations
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Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: Chun-Nan Yeh, MD Chang Gung Memorial Hospital, Linkou, Taiwan.
Principal Investigator: Jen-Shi Chen, MD. Chang Gung Memorial Hospital, Linkou, Taiwan.
Principal Investigator: Yen-Yang Chen, MD. Chang Gung Memorial Hospital, Kaoshung, Taiwan.
Principal Investigator: Kun-Chun Chiang, MD. Chang Gung Memorial Hospital, Keelung, Taiwan.
Principal Investigator: Liang-Mou Kuo, MD. Chang Gung Memorial Hospital, Cha-Yi, Taiwan.

Publications:
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Responsible Party: Chun-Nan Yeh, MD, Associate Professor, Dept. of General Surgery., Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01865565     History of Changes
Other Study ID Numbers: Yeh CN001
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Keywords provided by Chun-Nan Yeh, Chang Gung Memorial Hospital:
gastrointestinal stromal tumor
GIST
neoadjuvant
imatinib
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action