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Surgery

Surgery vs Stereotactic Ablative Radiotherapy for Lung Cancer (STABLE-MATES Trial)

Phase 3

Recruiting

Led By Robert Timmerman, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status (PS) 0, 1, or 2

All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (> 1 cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy, EUS/EBUS guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy within 180 days of randomization

Must not have

evidence of distant metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether a more targeted form of radiation therapy called SABR is more effective than the standard SR radiation therapy in treating operable stage I NSCLC.

Who is the study for?

This trial is for adults over 18 with high-risk operable Stage I non-small cell lung cancer (NSCLC) that can be removed by surgery. Candidates must have a tumor ≤ 4 cm, located peripherally in the lung, and no distant metastases. They should not have had previous thoracic radiation therapy or treatment for this lung cancer and must not be pregnant.

What is being tested?

The study aims to compare survival outcomes between two treatments: sublobar resection (SR), which is a type of lung surgery, and stereotactic ablative radiotherapy (SAbR). It's designed to see if SAbR offers better survival rates than SR in patients with early-stage NSCLC who are at high risk from traditional surgery.

What are the potential side effects?

Potential side effects of SR may include pain, bleeding, infection, or breathing difficulties post-surgery. SAbR could cause fatigue, skin reactions at the treatment site, shortness of breath or coughing up blood due to damage to surrounding lung tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My lung cancer has not spread to certain lymph nodes, confirmed by a biopsy.

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My tumor can be partially removed by surgery according to a lung surgeon.

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My cancer has not spread to distant parts of my body.

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I am considered high-risk for surgery based on specific health criteria.

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I am older than 18 years.

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My lung tumor is located away from the center of my lung.

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My lung scans show a type of lung cancer with more than half solid areas in the cloudy parts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

overall survival

Secondary study objectives

progression free survival

toxicity as assessed toxicity using the Common Toxicity Criteria

Side effects data

From 2013 Phase 3 trial • 397 Patients • NCT00004054

78%

Menopausal symptoms

60%

Urinary frequency

52%

Impotence

47%

Late RT Toxicity: Bladder: NOS

39%

Diarrhea NOS

27%

Late RT Toxicity: Bowel: NOS

26%

Fatigue

26%

Late RT Toxicity: Other GU: NOS

21%

Proctitis NOS

21%

Dysuria

14%

Libido decreased

14%

Dermatitis radiation NOS

12%

Late RT Toxicity: Other: NOS

12%

Late RT Toxicity: Other GI: NOS

12%

Hemoglobin decreased

12%

Alanine aminotransferase increased

Gynaecomastia

Urinary retention

Pain-other

Aspartate aminotransferase increased

Rectal bleeding

Constipation

Leukopenia NOS

Edema NOS

Hematuria present

Renal/GU-Other

Arthralgia

Blood creatinine increased

Dyspnea NOS

Dermatitis exfoliative NOS

Depression NEC

Nausea

Hyperglycemia NOS

Lymphopenia

Myalgia

Peripheral sensory neuropathy

Platelet count decreased

Hyponatremia

Hypocalcemia

Blood albumin decreased

Stomatitis

Weight decreased

Anorexia

Hematologic-Other

Neutropenia

Alopecia

100%

80%

60%

40%

20%

Study treatment Arm

Hormones and RT

Hormones and RT Plus Chemotherapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2 radiation therapyExperimental Treatment1 Intervention

Stereotactic Ablative Radiotherapy (SAbR)

Group II: Arm 1 lung surgeryActive Control1 Intervention

Sublobar Resection (SR)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation therapy

2013

Completed Phase 3

~2850

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,083 Previous Clinical Trials

1,057,917 Total Patients Enrolled

Robert Timmerman, MD4.25 ReviewsPrincipal Investigator - UTSW Medical Center

University of Texas Southwestern Medical Center

5 Previous Clinical Trials

10,201 Total Patients Enrolled

5Patient Review

I was nervous at first, but this wonderful doctor made me feel at ease and explained everything very well. I would definitely recommend him to others.