Phase I Study of Accelerated Hypofractionated Image-Guided Radiation Therapy

Non-small Cell Lung Cancer Clinical Trial

Official title: Phase I Study of Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-IV Non-Small Cell Lung Cancer and Poor Performance Status

Status Completed

Clinical Trial Summary

The study is designed to determine whether daily image guidance and motion assessment/control will allow treatment of poor performance status patients with stage II-IV NSCLC, who would benefit from local therapy, with an accelerated course of hypofractionated radiation therapy.

Clinical Trial Description

Subjects for this study will be enrolled by the Moncrief Radiation oncology Department at the Simmons Cancer Center.

Primary objective: To escalate the dose of accelerated, hypofractionated, image-guided conformal radiotherapy to a potent tumorcidal dose without exceeding the maximum tolerated dose in treatment of stage ii-iV nSCLC in patients with poor performance status.

Secondary objectives: To evaluate local regional tumor control and overall survival in patients with stage ii-iV nSCLC and poor performance status treated with accelerated, hypofractionated, image-guided conformal radiotherapy.

Schema

number of patients between 7-45 (depending on tolerance)

Patients in each dose cohort will all be treated as a single group for dose escalation. The starting dose will be 3.33 Gy per fraction for 15 fractions (total dose 50 Gy). Subsequent cohorts of patients will receive a higher dose per fraction as follows:

Cohort No. Fractions Dose per fraction (Gy) Total Dose (Gy) No. Patients

1. 15 3.33 50 7-15

2. 15 3.67 55 7-15

3. 15 4.00 60 7-15

Minimum waiting periods will be assigned between each dose cohort to observe toxicity.

Screening Procedures

each study participant will have the following exams, tests or procedure to help determine if they are qualified to be in this study:

Within 8 weeks of enrollment :

• Computed tomographic (CT) with contrast of the lung and upper abdomen. a CT done in conjunction with a Positron emission Tomography (PeT) scan is satisfactory as long as the images are of adequate quality to be interpreted by a radiologist.

• an MRi of the brain with contrast (or CT if MRi is medically contraindicated).

• Complete Blood Count (CBC) with differential

• Charleston Comorbidity index completion

Within 3 days prior to radiotherapy: urine or serum pregnancy test in females of child-bearing capacity.

Within 12 weeks of enrollment:

• Pulmonary function tests including spirometry for forced expiratory volume in 1 second (FeV-1), diffusing capacity (DLCo), and arterial blood gas (Pao-2).

Prior to enrollment on the study: Tissue biopsy or cytology confirming non-small cell lung cancer.

Treatment Protocol treatment must begin within 4 weeks after patient registration to the trial. Patients will receive 15 fractions of radiation. Total dose will depend on the dose cohort of the study (see schema). The starting dose level will be 3.33 Gy per fraction for 15 fractions (total dose [?] 50 Gy).

Patients must not receive other concomitant antineoplastic therapy (including standard fractionated radiotherapy to the chest, chemotherapy, biological therapy, vaccine therapy, and surgery) within a week prior to, during, or within one week after completing hypofractionated image-guided radiation therapy on protocol.

Follow-up Patients will be followed until death. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

• NCT number: NCT03623334
• Study type: Interventional
• Source: University of Texas Southwestern Medical Center
• Status: Completed
• Phase: N/A
• Start date: October 5, 2009
• Completion date: February 10, 2018