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

February 17, 2015 updated by: David Palma, Lawson Health Research Institute
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program of the Lawson Health Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Shrinking Target Adaptive Radiotherapy
Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Radiation: Adaptive radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor reduction
Time Frame: 2.5 years (end of treatment)
2.5 years (end of treatment)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

London Regional Cancer Program, Canada

Investigators

  • Principal Investigator: David Palma, MD, PhD, London Regional Cancer Program of the Lawson Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (Estimate)

July 23, 2012

Study Record Updates

Last Update Posted (Estimate)

February 19, 2015

Last Update Submitted That Met QC Criteria

February 17, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lung-START

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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