Phase I/II Study of Fractionated Stereotactic Radiotherapy for Early Stage Non-Small Cell Lung Cancer

AHS Cancer Control Alberta

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Radiation: Stereotactic Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00888823

24541/ethics24761

Details and patient eligibility

About

A new type of treatment called stereotactic radiotherapy has recently been developed in hopes of improving the success of the treatment and improving the convenience to patients, while reducing the side effects. This study is developing stereotactic radiotherapy as a state-of-the-art treatment for lung cancer patients.

Full description

OBJECTIVES:

Primary Objectives

• To determine the efficacy of hypofractionated, image guided radiotherapy in treating patients with lung tumours, with the primary outcome being local control at one year.
• To determine the toxicity of high dose, small field,hypofractionated radiotherapy to the lung, based on the RTOG and CTCAE scales.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• T1-T3N0 non-small cell lung cancer (maximum dimensions of 5cm, T3 by chestwall involvement only)
• Medically inoperable due to co-morbid conditions or patient preference for radiation
• adequate pulmonary function to withstand radical treatment (ie. FEV1 greater than 40% of predicted), as assessed by consulting radiation oncologist
• age greater than or equal to 18, and Karnofsky performance status greater than of equal to 70

Exclusion criteria

• Presence of mediastinal metastases or distant metastases
• Life expectancy less than 1 year due to other co-morbid conditions

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)