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

This study has been terminated.
(Lack of enrollment)
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Accuray Incorporated
ClinicalTrials.gov Identifier:
NCT00840749
First received: February 7, 2009
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Radiation: CyberKnife Stereotactic Radiotherapy
Procedure: Surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: International Randomized Study to Compare CyberKnife® Stereotactic Radiotherapy With Surgical Resection in Stage I Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Accuray Incorporated:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare disease specific survival, progression free survival at the treated primary tumor site, grade 3 and above acute and/or chronic toxicities,and evaluate predictive value of pre and post treatment PET scan in clinical outcome [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 2008
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CyberKnife Stereotactic Radiotherapy Radiation: CyberKnife Stereotactic Radiotherapy
Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy
Other Name: CyberKnife SBRT, CyberKnife SRT, CyberKnife SRS
Active Comparator: Surgery Procedure: Surgery
Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings
Other Name: Open thoracotomy, video assisted thoracotomy (VATS)

Detailed Description:

Objectives:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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.

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 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840749

Locations
United States, California
Community Regional Medical Center
Fresno, California, United States, 93721
United States, Colorado
Penrose Cancer Center
Colorado Springs, Colorado, United States, 80907
Denver CyberKnife
Lone Tree, Colorado, United States, 80124
United States, Florida
Jupiter Medical Center
Jupiter, Florida, United States, 33458
United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
United States, Indiana
Parkview Cancer Center
Fort Wayne, Indiana, United States, 46845
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Michigan
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
St. Mary's of Michigan
Saginaw, Michigan, United States, 48601
United States, Minnesota
St. Mary's Duluth Clinic Health System
Duluth, Minnesota, United States, 55805
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63110
United States, Nevada
St. Mary's
Reno, Nevada, United States, 89503
United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
China, Guangxi
Ruikang Hospital
Nanning, Guangxi, China, 530011
China, Tianjin
Tianjin Cancer Institute and Hospital
Hexi District, Tianjin, China, 300060
France
Centre Oscar Lambret
Lille, France, 59000
Centre Antoine Lacassagne
Nice, France, 06189
Taiwan
CyberKnife Center of WanFang Medical Hospital
Taipei, Taiwan
Sponsors and Collaborators
Accuray Incorporated
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jack Roth, M.D. M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Accuray Incorporated
ClinicalTrials.gov Identifier: NCT00840749     History of Changes
Other Study ID Numbers: STARS
Study First Received: February 7, 2009
Last Updated: April 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Accuray Incorporated:
STARS
Early Stage Non Small Cell Lung Cancer
NSCLC
CyberKnife
Surgery
Accuray

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 14, 2014