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International Randomized Study to Compare CyberKnife® Stereotactic Radiotherapy With Surgical Resection in Stage I Non-small Cell Lung Cancer

Phase 3
18 Years
Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

International Randomized Study to Compare CyberKnife® Stereotactic Radiotherapy With Surgical Resection in Stage I Non-small Cell Lung Cancer


Primary Goal: To compare overall survival at 3 years.

Secondary goals:

1. To compare disease specific survival at 3 years.

2. To compare 3 year progression free survival at the treated primary tumor site

3. To compare grade 3 and above acute and/or chronic toxicities.

4. To evaluate predictive value of pre and post treatment PET scan in clinical outcome.

Inclusion 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

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.

Exclusion 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

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).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Jack Roth, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

December 2008

Completion Date:

March 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Early Stage Non Small Cell Lung Cancer
  • CyberKnife
  • Surgery
  • Accuray
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Central Baptist HospitalLexington, Kentucky  40503
Advocate Christ Medical CenterOak Lawn, Illinois  60453
Penrose Cancer CenterColorado Springs, Colorado  80933
St. Joseph Mercy HospitalPontiac, Michigan  48341-2985
Saint Louis UniversitySt. Louis, Missouri  63104
U.T. M.D. Anderson Cancer CenterHouston, Texas  77030
St. Luke's Episcopal HospitalHouston, Texas  77030
Jupiter Medical CenterJupiter, Florida  33458
Community Regional Medical CenterFresno, California  93721
Denver CyberKnifeLone Tree, Colorado  80124
Parkview Cancer CenterFort Wayne, Indiana  46845
St. Mary's of MichiganSaginaw, Michigan  
St. Mary's Duluth Clinic Health SystemDuluth, Minnesota  55805
St. Mary'sReno, Nevada  89503