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

Not Applicable

Terminated

• Conditions: Non Small Cell Lung Cancer
• Interventions: Radiation: Adaptive radiotherapy

• Registration Number: NCT01647334
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-23
• Study Start: 2013-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-17
• Last Update Posted: 2015-02-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shrinking Target Adaptive Radiotherapy	Adaptive radiotherapy	Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer

Primary Outcome Measures

Name	Time	Method
Tumor reduction	2.5 years (end of treatment)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

London Regional Cancer Program of the Lawson Health Research Institute; 🇨🇦 London, Ontario, Canada