Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

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

CyberKnife Stereotactic Radiotherapy

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

Surgery

Jack Roth, M.D.

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.

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.

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

International Randomized Study to Compare CyberKnife® Stereotactic Radiotherapy With Surgical Resection in Stage I Non-small Cell Lung Cancer

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.

M.D. Anderson Cancer Center

Accuray Incorporated

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

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

Total

Age, Categorical

Age at evaluation (date of evaluation - date of birth)

Age, Continuous

Sex: Female, Male

Missing

patient's level of functioning/quality of daily life

0 - Fully active, able to carry on all pre-disease performance without restriction

1. - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
2. - Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
3. - Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
4. - Completely disabled; cannot carry on any selfcare
5. - Dead

ECOG/Zubrod performance status

T stage size/extension of tumor

T0: No evidence of primary tumor T1a: Melanoma ≤1.0 mm in thickness without ulceration and mitoses \< 1/mm 2 T1b: Melanoma ≤1.0 mm in thickness with ulceration or mitoses ≥ 1/mm 2 T2a: Melanomas 1.01-2.0 mm in thickness without ulceration T2b: Melanomas 1.01-2.0 mm in thickness with ulceration

Primary Tumour stage

Peripheral

Central

Lesion Type

study admin

At the time of study closure, 20 patients were treated on the CyberKnife arm and 16 on the Surgery arm. Two deaths were captured on the Surgery arm during the course of the study and one patient enrolled on the CyberKnife arm passed away before being treated with CyberKnife.

Overall Survival

Pts enrolled at MD Anderson

Pts enrolled from other sites

Age: 40-49

Age: 50-59

Age: 60-69

Age: 70-79

Age: 80-89

Male

Female

Central Tumor

Peripheral Tumor

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.

No patients randomized in either treatment arm made it to 3 years follow-up. No further data was collected or will be collected on the patient population.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer	NCT00840749	Non-small Cell ...	CyberKnife Ster... Surgery	18 Years -	Accuray Incorporated
Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer	NCT00840749	Non-small Cell ...	CyberKnife Ster... Surgery	18 Years -	Accuray Incorporated

Spots Global Cancer Trial Database for early stage non small cell lung cancer