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Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer (STARS)
This study is currently recruiting participants.
Verified February 2012 by Accuray Incorporated

First Received on February 7, 2009.   Last Updated on February 23, 2012   History of Changes
Sponsor: Accuray Incorporated
Collaborator: M.D. Anderson Cancer Center
Information provided by (Responsible Party): Accuray Incorporated
ClinicalTrials.gov Identifier: NCT00840749
  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 ]

Estimated Enrollment: 420
Study Start Date: December 2008
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (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

Contacts
Contact: Jan Jenkins (408) 338-9372 jjenkins@accuray.com
Contact: Omar Dawood, MD, MPH 408-789-4457 odawood@accuray.com

  Show 21 Study Locations
Sponsors and Collaborators
Accuray Incorporated
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jack Roth, M.D. M.D. Anderson Cancer Center
  More Information

Additional 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: February 23, 2012
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 May 23, 2012