Clinical trial · Interventional
Evaluation of Patients With Bulky GIST Using Sunitinib
Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST
NCT01054911CI-TRIAL-00023979terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual
Summary
Brief summary (as posted)
The primary purpose of this study is to determine if oral (mouth) delivery prior to tumor removal in patients with gastrointestinal stromal tumor (GIST) results in tumor shrinkage allowing for successful surgery. Therapy will be administered orally and the response of the tumor will be assessed using CTs or MRIs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunitinib | Drug | Sunitinib | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sunitinib pill
- description
- Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.
- interventionNames
- Drug: Sunitinib
- Procedure: Surgery
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- 6 months
Secondary outcomes (2)
- measure
- Measurable Disease Response Rate
- timeFrame
- FDG PET scan at baseline and Week 2, CT scan at baseline and Week 12
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients more than 19 years old with pathologically proven GIST which is bulky or marginally resectable * Patients must have at least one bidimensionally measurable disease site of 5 cm or greater not previously irradiated. Bone lesions do not qualify. * Patients must have an ECOG performance of greater than or equal to 2, with projected survival of at least three months. * Patients must have adequate laboratory parameters: Hematologic: Hb \>9.0; WBC \>3200 and platelets \>100,000/mm3; Hepatic: Bilirubin \<2.0 and AST within 4 times upper limit of normal; Renal: Creatinine of less than or equal to 1.6 or eGFR greater than or equal to 50 mL/min * Men and women who are of childbearing potential must practice strict birth control for the duration of the study. * Women of childbearing potential must be non-lactating and non-pregnant with a negative pregnancy test within two weeks of trial registration. * The patient, a witness, and attending physician will have signed an IRB-approved informed consent prior to Sunitinib administration. Exclusion Criteria: * Known brain metastases or significant pleural effusion or ascites. * Uncontrolled hypertension, diabetes, or other medical condition. * Major surgery within 21 days of registration. * Patients wtih organ grafts with the exception of prior high dose chemotherapy with autologous bone marrow (or stem cell) transplantation. * History of seizures, central nervous system disorders, dementia, or psychosis that might preclude adequate informed consent or protocol compliance. * Prior therapy for GIST. * A history of HIV or hepatitis virus infection. * Any recent medical condition which, in the opinion of the investigator, makes the patient unsuitable for study participation. * Patients with impaired kidney function.
References
Publications (0)
Data not yet available
No reference posted for this study.