- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00840749
Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer (STARS)
International Randomized Study to Compare CyberKnife® Stereotactic Radiotherapy With Surgical Resection in Stage I Non-small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives:
Primary Goal: To compare overall survival at 3 years.
Secondary goals:
- To compare disease specific survival at 3 years.
- To compare 3 year progression free survival at the treated primary tumor site
- To compare grade 3 and above acute and/or chronic toxicities.
- To evaluate predictive value of pre and post treatment PET scan in clinical outcome.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guangxi
-
Nanning, Guangxi, China, 530011
- Ruikang Hospital
-
-
Tianjin
-
Hexi Linchang, Tianjin, China, 300060
- Tianjin Cancer Institute and Hospital
-
-
-
-
-
Lille, France, 59000
- Centre Oscar Lambret
-
Nice, France, 06189
- Centre Antoine LACASSAGNE
-
-
-
-
-
Taipei, Taiwan
- CyberKnife Center of WanFang Medical Hospital
-
-
-
-
California
-
Fresno, California, United States, 93721
- Community Regional Medical Center
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80907
- Penrose Cancer Center
-
Lone Tree, Colorado, United States, 80124
- Denver CyberKnife
-
-
Florida
-
Jupiter, Florida, United States, 33458
- Jupiter Medical Center
-
-
Illinois
-
Oak Lawn, Illinois, United States, 60453
- Advocate Christ Medical Center
-
-
Indiana
-
Fort Wayne, Indiana, United States, 46845
- Parkview Cancer Center
-
-
Kentucky
-
Lexington, Kentucky, United States, 40503
- Central Baptist Hospital
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48106
- St. Joseph Mercy Hospital
-
Saginaw, Michigan, United States, 48601
- St. Mary's of Michigan
-
-
Minnesota
-
Duluth, Minnesota, United States, 55805
- St. Mary's Duluth Clinic Health System
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Saint Louis University
-
-
Nevada
-
Reno, Nevada, United States, 89503
- St. Mary's
-
-
Texas
-
Houston, Texas, United States, 77030
- St. Luke's Episcopal Hospital
-
Houston, Texas, United States, 77030
- U.T. M.D. Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
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
- 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.
- 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.
- Patients must be ≥ 18 years of age.
- The patient's Zubrod performance status must be Zubrod 0-2.
- Mandatory staging studies: Must be done within 8 weeks prior to study entry
- Patients must sign a study-specific consent form.
- 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:
- Patients with primary tumors > 4 cm;
- Patients with well-differentiated neuroendocrine carcinoma (carcinoid tumor)
- 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;
- Previous lung or mediastinal radiotherapy;
- Plans for the patient to receive other concomitant local therapy (including standard fractionated radiotherapy and surgery) while on this protocol except at disease progression;
- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus;
- Cannot achieve acceptable SRT planning to meet minimal requirement of target coverage and dose-volume constraints of critical structures (see RT techniques).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 Names:
|
Experimental: 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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 3 years
|
The study power was calculated for sample size of 420 patients, enrolled over 7 years. The actual enrollment was 36 patients over 4 years. The study was therefore terminated due to lack of enrollment. The sample size does not allow to analysis of the primary outcome. While the study data is not mature enough to evaluate the endpoints of the study, we will attempt to describe the results gleaned from the existing patient population. |
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jack Roth, M.D., M.D. Anderson Cancer Center
Publications and helpful links
General Publications
- Park S, Kim HJ, Park IK, Kim YT, Kang CH. Stereotactic ablative radiotherapy versus surgery in older patients with stage I lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):74-80. doi: 10.1093/ejcts/ezab045.
- Chang JY, Senan S, Paul MA, Mehran RJ, Louie AV, Balter P, Groen HJ, McRae SE, Widder J, Feng L, van den Borne BE, Munsell MF, Hurkmans C, Berry DA, van Werkhoven E, Kresl JJ, Dingemans AM, Dawood O, Haasbeek CJ, Carpenter LS, De Jaeger K, Komaki R, Slotman BJ, Smit EF, Roth JA. Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomised trials. Lancet Oncol. 2015 Jun;16(6):630-7. doi: 10.1016/S1470-2045(15)70168-3. Epub 2015 May 13. Erratum In: Lancet Oncol. 2015 Sep;16(9):e427.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STaRS (Registry Identifier: STaRS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-small Cell Lung Cancer
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
Clinical Trials on CyberKnife Stereotactic Radiotherapy
-
Essentia HealthActive, not recruitingBreast CancerUnited States
-
Boston Medical CenterActive, not recruitingProstate CancerUnited States
-
Juravinski Cancer CenterCanadian Breast Cancer Foundation; Juravinski Cancer Centre FoundationUnknownBreast NeoplasmCanada
-
University of Texas Southwestern Medical CenterCompletedEarly-stage Glottic Larynx CancerUnited States
-
Stanford UniversityTerminated
-
UNC Lineberger Comprehensive Cancer CenterCompletedLiver Neoplasms | Colonic Neoplasms | Metastatic Cancer to LiverUnited States
-
MemorialCare Health SystemRecruiting
-
Accuray IncorporatedCompletedProstatic Neoplasms | Prostate Cancer | Prostate Neoplasms | Cancer of the Prostate | Prostatic CancerUnited States
-
Accuray IncorporatedCompletedProstatic Neoplasms | Prostate Cancer | Prostate Neoplasms | Cancer of the Prostate | Prostatic CancerUnited States
-
Accuray IncorporatedUniversity of PittsburghUnknownNon-small Cell Lung CancerUnited States, China