TRIAL DETAIL

Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor (RTOG-S-0132)

Drug:	Imatinib
Trial Name:	Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor (RTOG-S-0132)
NCT#:	NCT00028002
Conditions:	Gastrointestinal Stromal Tumor
Status:	Completed
Phase:	2	Start Date 02/28/2002	Age of Trial (yrs) 22.6
Treatment Phase:	Adjuvant Neoadjuvant
Drug Category:	KIT/PDGFRA inhibitor
Strategy:	Block KIT
Trial Type:	Specifically GIST and only GIST
Other Protocol IDs:	RTOG 0132-S0132
Sponsor:	Radiation Therapy Oncology Group National Cancer Institute (NCI) American College of Radiology Imaging Network Eastern Cooperative Oncology Group
Patient Contact:	See clinicaltrials.gov
Contact email:
Contact Phone:
Randomized:
IV or Oral:	Oral
Trial Notes:	OBJECTIVES: * Determine the progression-free survival of patients with primary or recurrent potentially resectable malignant gastrointestinal stromal tumor treated with neoadjuvant and adjuvant imatinib mesylate. * Determine the objective response rate of patients treated with this drug. * Determine the safety of this drug in these patients. OUTLINE: Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 2 years.