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

NCT00840749 | Terminated Results DMC

• 1 other identifier: STARS
• Study Type: interventional
• Target: 36
• Locations: 4 countries
• Sites: 19

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.

Conditions

Non-small Cell Lung Cancer

Keywords

STARS; Early Stage Non Small Cell Lung Cancer; NSCLC; CyberKnife; Surgery; Accuray

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  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

Study Arms (2)

CyberKnife Stereotactic Radiotherapy

EXPERIMENTAL

Radiation: CyberKnife Stereotactic Radiotherapy

Surgery

ACTIVE COMPARATOR

Procedure: Surgery

Interventions

CyberKnife Stereotactic Radiotherapy RADIATION

Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy

Also known as: CyberKnife SBRT, CyberKnife SRT, CyberKnife SRS

CyberKnife Stereotactic Radiotherapy

Surgery PROCEDURE

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

Also known as: Open thoracotomy, video assisted thoracotomy (VATS)

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Accuray Incorporated: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (19)

Community Regional Medical Center

Fresno, California, 93721, United States

Location

Penrose Cancer Center

Colorado Springs, Colorado, 80907, United States

Location

Denver CyberKnife

Lone Tree, Colorado, 80124, United States

Location

Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Parkview Cancer Center

Fort Wayne, Indiana, 46845, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

St. Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

St. Mary's of Michigan

Saginaw, Michigan, 48601, United States

Location

St. Mary's Duluth Clinic Health System

Duluth, Minnesota, 55805, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

St. Mary's

Reno, Nevada, 89503, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Ruikang Hospital

Nanning, Guangxi, 530011, China

Location

Tianjin Cancer Institute and Hospital

Hexi Linchang, Tianjin Municipality, 300060, China

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

CyberKnife Center of WanFang Medical Hospital

Taipei, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 33668061 DERIVED

• 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.

  PMID: 25981812 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Surgical Procedures, Operative; Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures

Results Point of Contact

• Title: study admin
• Organization: Accuray Inc

ccheung@accuray.com

4087164608

Study Officials

• Jack Roth, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2009
• First Posted: February 10, 2009
• Study Start: December 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 14, 2020
• Results First Posted: July 14, 2020

Record last verified: 2020-02

Locations

TW (1); FR (2); US (14); CN (2)