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

2014-08-27 03:24:26 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Non-small Cell Lung Cancer

Intervention

CyberKnife Stereotactic Radiotherapy, Surgery

Location

Community Regional Medical Center
Fresno
California
United States
93721

Status

Recruiting

Source

Accuray Incorporated

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:24:26-0400

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Medical and Biotech [MESH] Definitions

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).

Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.

A radiological stereotactic technique developed for cutting or destroying tissue by high doses of radiation in place of surgical incisions. It was originally developed for neurosurgery on structures in the brain and its use gradually spread to radiation surgery on extracranial structures as well. The usual rigid needles or probes of stereotactic surgery are replaced with beams of ionizing radiation directed toward a target so as to achieve local tissue destruction.

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