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

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ClinicalTrials.gov Identifier: NCT00840749
Recruitment Status : Terminated (Lack of enrollment)
First Posted : February 10, 2009
Last Update Posted : April 8, 2013
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Accuray Incorporated

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840749


Locations
Show Show 19 study locations
Sponsors and Collaborators
Accuray Incorporated
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Jack Roth, M.D. M.D. Anderson Cancer Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Accuray Incorporated
ClinicalTrials.gov Identifier: NCT00840749    
Other Study ID Numbers: STARS
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013
Keywords provided by Accuray Incorporated:
STARS
Early Stage Non Small Cell Lung Cancer
NSCLC
CyberKnife
Surgery
Accuray
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms