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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01647334
• Other study ID #: Lung-START
• Status: Terminated
• Phase: N/A
• First received: July 19, 2012
• Last updated: February 17, 2015
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Radiation:
• Adaptive radiotherapy

Locations

Country	Name	City	State
Canada	London Regional Cancer Program of the Lawson Health Research Institute	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	London Regional Cancer Program, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor reduction		2.5 years (end of treatment)	No
Secondary	Rate of tumor shrinkage		2.5 years (end of treatment)	No
Secondary	Change in lung dose		2.5 years (end of treatment)	No
Secondary	Delivered doses		2.5 years (end of treatment)	No
Secondary	Radiation pneumonitis rates		6 months, 12 months, 18 months, 24 months, 30 months (semi-annually)	Yes
Secondary	Local control		2.5 years (end of treatment)	No
Secondary	Overall survival		2.5 years	No