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Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy

ConditionLung Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

Patients with stage I non-small cell lung cancer have been historically treated with surgery whenever they are fit for an operation. However, an alternative treatment known as stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors believe both are good treatments and are therefore conducting this study to determine if one may be possibly better than the other.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older

Any patient with a preliminary diagnosis of stage I Non-Small Cell Lung Cancer (NSCLC), whether pathologically proven by biopsy, or highly suspicious by radiographic imaging. [Participants will ultimately need biopsy confirmation before enrolling]

Primary tumor size less than or equal to 5 cm by CT (may include CT images from PET/CT)

Karnofsky performance status greater than or equal to 70

Disqualifiers

Previously evaluated by a local thoracic surgeon and determined to be medically inoperable

Pathological confirmation of nodal or distant metastasis

Prior history of lung cancer, not including current lesion

Prior history of thoracic surgery or lung or esophageal cancer. [prior cardiac surgery acceptable]

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stereotactic Radiotherapy

    Radiation

    Stereotactic radiotherapy uses high doses of ionizing energy to treat cancer cells with image guidance. The treatment is delivered in an outpatient setting, and for purposes of this trial is delivered in 3-5 fractions.

  • Anatomic Pulmonary Resection

    Procedure/Surgery

    An anatomic pulmonary resection is an oncologic procedure that dissects out an anatomically defined segment of the lung to remove all of the lung tissue around a lung tumor. It requires an operation with general anesthesia, with a short hospital stay. The procedure entails removal of lymph nodes inside the chest that might not be easily accessible without an operation.

Treatment groups

670 Participants
are divided into 2 treatment groups
Group A: Stereotactic radiotherapyExperimental treatment 1 intervention
Group B: SurgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival

Survival estimates will include death from any cause.

Time frame
From date of randomization through study completion, up to 10 years

Secondary outcomes

1

Patient reported health-related quality of life

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Lung Cancer (LC 13) survey instruments will assess patients' general state of physical, social/family, emotional and functional well-being.

Time frame
5 years
2

Respiratory Function

The St George's Respiratory Questionnaire will evaluate respiratory symptoms, activity limitations from breathlessness, and impact of respiratory function on social and psychological functioning.

Time frame
5 years
3

Health State Utilities

The EQ-5D-5L (EuroQOL-5D) survey will measure quality adjusted life years.

Time frame
5 years
4

Lung cancer mortality

Cause of death will be determined by an independent adjudication committee.

Time frame
From date of randomization until date of death from any cause, assessed up to 10 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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