Clinical trial NCT00840749: Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer
Official title: International Randomized Study to Compare CyberKnife® Stereotactic Radiotherapy With Surgical Resection in Stage I Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: STARS
Early Stage Non Small Cell Lung Cancer
NSCLC
CyberKnife
Surgery
Accuray
Lead sponsor: Accuray Incorporated
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2009-02-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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).

Primary outcomes:
measure: Overall Survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
city: Colorado Springs
country: United States
facility: Penrose Cancer Center
state: Colorado
city: Lone Tree
country: United States
facility: Denver CyberKnife
state: Colorado
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Cancer Center
state: Indiana
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Saginaw
country: United States
facility: St. Mary's of Michigan
state: Michigan
city: Duluth
country: United States
facility: St. Mary's Duluth Clinic Health System
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Reno
country: United States
facility: St. Mary's
state: Nevada
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Houston
country: United States
facility: U.T. M.D. Anderson Cancer Center
state: Texas
city: Nanning
country: China
facility: Ruikang Hospital
state: Guangxi
city: Hexi Linchang
country: China
facility: Tianjin Cancer Institute and Hospital
state: Tianjin
city: Lille
country: France
facility: Centre Oscar Lambret
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Taipei
country: Taiwan
facility: CyberKnife Center of WanFang Medical Hospital
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jack Roth, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.