Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer

Lawson Health Research Institute1 site in 1 country29 target enrollmentJanuary 2013

ConditionsNon Small Cell Lung Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non Small Cell Lung Cancer
Sponsor: Lawson Health Research Institute
Enrollment: 29
Locations: 1
Primary Endpoint: Tumor reduction
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to use a type of radiation (adaptive radiotherapy) to deliver curative-intent treatment to patients with non-small cell lung cancer, whose tumors would otherwise be too large for standard curative treatment. The study will use adaptive radiotherapy to achieve these goals. Adaptive radiotherapy is a process whereby treatment plans are modified during the course of treatment due to patient and tumor variations (ie. weight loss or tumor shrinkage). This may allow for dose escalation, while limiting the side effects.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

December 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Lawson Health Research Institute

Responsible Party

Principal Investigator

David Palma

Principal Investigator

Lawson Health Research Institute

Eligibility Criteria

Inclusion Criteria

•Age 18 or older
•Willing to provide informed consent
•ECOG performance status 0-2
•Histologically confirmed non-small cell lung carcinoma
•Locally advanced stage IIIA or IIIB lung carcinoma according to AJCC 7th edition
•Expected lung V20 of 35-60%, as determined at the time of 4D-CT simulation
•Assessment by medical oncologist and radiation oncologist, with adequate hepatic and renal function for administration of cisplatin-based doublet chemotherapy, at the discretion of the medical oncologist

Exclusion Criteria

•Serious medical comorbidities or other contraindications to radiotherapy or chemotherapy
•Prior history of lung cancer within 5 years
•Prior thoracic radiation at any time
•Metastatic disease
•in some select cases, patients with a solitary metastasis (i.e. brain metastasis) may receive radical chemoradiotherapy after resection/ablation of their metastatic lesion, as standard practice. In such cases, the patient may be enrolled onto this study at the discretion of the local principle investigator once the metastasis has been treated.
•inability to attend full course of radiotherapy of follow-up visits
•Pregnant or lactating women

Outcomes

Primary Outcomes

Tumor reduction

Time Frame: 2.5 years (end of treatment)

Secondary Outcomes

Radiation pneumonitis rates(6 months, 12 months, 18 months, 24 months, 30 months (semi-annually))
Rate of tumor shrinkage(2.5 years (end of treatment))
Overall survival(2.5 years)
Change in lung dose(2.5 years (end of treatment))
Delivered doses(2.5 years (end of treatment))
Local control(2.5 years (end of treatment))