Surgery for Locally Unresectable Advanced GISTs Without Metastasis After Imatinib Therapy

NCT01865565 | Completed DMC

• 1 other identifier: Yeh CN001
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Stromal Tumor

Keywords

gastrointestinal stromal tumor; GIST; neoadjuvant; imatinib

Outcome Measures

Primary Outcomes (1)

• progression free survival

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

  five years

Secondary Outcomes (5)

• R0 resection rate

  three years

• Objective response rate, tumor shrinkage rate

  three years

• Correlation of PK with response

  three years

• Surgical morbidity and mortality and safety follow up

  five years

• Overall survival (OS)

  five years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (4)

• Pawlik TM, Vauthey JN, Abdalla EK, Pollock RE, Ellis LM, Curley SA. Results of a single-center experience with resection and ablation for sarcoma metastatic to the liver. Arch Surg. 2006 Jun;141(6):537-43; discussion 543-4. doi: 10.1001/archsurg.141.6.537.

  PMID: 16785353 BACKGROUND

• Dagher R, Cohen M, Williams G, Rothmann M, Gobburu J, Robbie G, Rahman A, Chen G, Staten A, Griebel D, Pazdur R. Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors. Clin Cancer Res. 2002 Oct;8(10):3034-8.

  PMID: 12374669 BACKGROUND

• Demetri GD, von Mehren M, Blanke CD, Van den Abbeele AD, Eisenberg B, Roberts PJ, Heinrich MC, Tuveson DA, Singer S, Janicek M, Fletcher JA, Silverman SG, Silberman SL, Capdeville R, Kiese B, Peng B, Dimitrijevic S, Druker BJ, Corless C, Fletcher CD, Joensuu H. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med. 2002 Aug 15;347(7):472-80. doi: 10.1056/NEJMoa020461.

  PMID: 12181401 BACKGROUND

• Blanke CD, Rankin C, Demetri GD, Ryan CW, von Mehren M, Benjamin RS, Raymond AK, Bramwell VH, Baker LH, Maki RG, Tanaka M, Hecht JR, Heinrich MC, Fletcher CD, Crowley JJ, Borden EC. 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. J Clin Oncol. 2008 Feb 1;26(4):626-32. doi: 10.1200/JCO.2007.13.4452.

  PMID: 18235122 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Histologically verified GIST and exon genotype.

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Chun-Nan Yeh, MD

  Chang Gung Memorial Hospital, Linkou, Taiwan.

  STUDY CHAIR

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor, Dept. of General Surgery.

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 31, 2013
• Study Start: January 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2017
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

TW (1)