TerminatedNot applicableNCT00840749
Official study title

Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer

Study summary

Lung cancer remains the most frequent cause of cancer death in both men and women in the world. Surgical resection using lobectomy with mediastinal lymph node dissection or sampling has been a standard of care for operable early stage NSCLC. Several studies have reported high local control and survival using SBRT in stage I NSCLC patients. SBRT is now an accepted treatment for medically inoperable patients with stage I NSCLC and patients with operable stage I lung cancer are entered on clinical protocols. The purpose of this study is to conduct a phase III randomized study to compare CyberKnife SBRT with surgery, the current standard of care for stage I operable NSCLC.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCyberKnife Stereotactic Radiotherapy and Surgery

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 14, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?19 U.S. locations

Locations may change over time.

Who runs it?Accuray Incorporated

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Accuray Incorporated
Interventions being studied
Radiation: CyberKnife Stereotactic Radiotherapy; Procedure: Surgery
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Histological confirmation of non-small cell cancer will be required by either biopsy or cytology. The following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma with or without BAC features, large cell carcinoma with or without neuroendocrine features, neuroendocrine carcinoma, bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified. 2. Eligible patients must have appropriate staging studies identifying them as specific subsets of the revised IASCL state IA or IB based on only one of the following combinations of TNM staging: T1, N0, M0 or T2 (\<=4 cm), N0, M0 3. A PET/CT scan is required. Patients with hilar or mediastinal lymph nodes with short axis diameter \< 1 cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with \> 1 cm short axis diameter of hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. Solitary pulmonary lesions \<4 mm will not be considered significant. 4. The patients must be considered a reasonable candidate for surgical resection of the primary tumor. Standard justification for deeming a patient medically operable based on pulmonary function for surgical resection of NSCLC may include any of the following: Baseline FEV1 \> 40% predicted, post-operative predicted FEV1 \> 30% predicted, diffusion capacity \> 40% predicted, absent baseline hypoxemia and/or hypercapnia, exercise oxygen consumption \> 50% predicted, absent severe pulmonary hypertension, absent severe cerebral, cardiac, or peripheral vascular disease, and absent severe chronic heart disease. 5. Patients must be ≥ 18 years of age. 6. The patient's Zubrod performance status must be Zubrod 0-2. 7. Mandatory staging studies: Must be done within 8 weeks prior to study entry 8. Patients must sign a study-specific consent form. 9. Patients (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study.

Reasons someone may not be able to joinExclusion criteria

1. Patients with primary tumors \> 4 cm; 2. Patients with well-differentiated neuroendocrine carcinoma (carcinoid tumor) 3. Direct evidence of regional or distant metastases after appropriate staging studies, or synchronous primary or prior malignancy in the past 5 years other than nonmelanomatous skin cancer or in situ cancer; 4. Previous lung or mediastinal radiotherapy; 5. Plans for the patient to receive other concomitant local therapy (including standard fractionated radiotherapy and surgery) while on this protocol except at disease progression; 6. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus; 7. Cannot achieve acceptable SRT planning to meet minimal requirement of target coverage and dose-volume constraints of critical structures (see RT techniques).

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Community Regional Medical CenterFresno, California
  • Penrose Cancer CenterColorado Springs, Colorado
  • Denver CyberKnifeLone Tree, Colorado
  • Jupiter Medical CenterJupiter, Florida
  • Advocate Christ Medical CenterOak Lawn, Illinois
  • Parkview Cancer CenterFort Wayne, Indiana
  • Central Baptist HospitalLexington, Kentucky
  • St. Joseph Mercy HospitalAnn Arbor, Michigan
  • St. Mary's of MichiganSaginaw, Michigan
  • St. Mary's Duluth Clinic Health SystemDuluth, Minnesota
  • Saint Louis UniversitySt Louis, Missouri
  • St. Mary'sReno, Nevada

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 14, 2020. Always confirm current availability with the study team.

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