Sublobar Resection or Stereotactic Ablative Radiotherapy in Treating Patients with Stage I Non-small Cell Lung Cancer, The STABLE-MATES Trial

Active:	Yes
Cancer Type:	Lung Cancer Unknown Primary	NCT ID:	NCT02468024
Trial Phases:	Phase III	Protocol IDs:	SCCC-02515; STU 022015-069 (primary) NCI-2015-01676
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	UT Southwestern/Simmons Cancer Center-Dallas
NCI Full Details:	http://clinicaltrials.gov/show/NCT02468024

Summary

This phase III trial compares sublobar resection (surgery to remove a portion of a lobe) and stereotactic ablative radiotherapy to see how well they work in treating patients with stage I non-small cell lung cancer. Sublobar resection is a less invasive type of surgery for non-small cell lung cancer and may have fewer side effects and improve recovery. Stereotactic radiosurgery, also known as stereotactic ablation radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. It is not yet known whether sublobar resection is more effective than stereotactic ablative radiotherapy in treating patients with non-small cell lung cancer.

Objectives

PRIMARY OBJECTIVE:
I. To test the hypothesis that overall survival rate in high risk operable patients with stage I non-small cell lung cancer (NSCLC) is greater in patients who undergo stereotactic ablative radiotherapy (SAbR) as compared to standard sublobar resection (SR).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo sublobar resection.

ARM II: Patients undergo stereotactic ablative radiotherapy over approximately 60 minutes for 3 fractions within 16 days.

After completion of study treatment, patients are followed up at 4 weeks, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months.

Treatment Sites in Georgia

Curtis and Elizabeth Anderson Cancer Institute at Memorial University Medical Center
4700 Waters Avenue
Savannah, GA 31404
912-350-8913
www.memorialhealth.com/anderson-cancer-institute.aspx

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