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

Primary Purpose

Non Small Cell Lung Cancer

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Adaptive radiotherapy
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • London Regional Cancer Program of the Lawson Health Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shrinking Target Adaptive Radiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Tumor reduction

Secondary Outcome Measures

Rate of tumor shrinkage
Change in lung dose
Delivered doses
Radiation pneumonitis rates
Local control
Overall survival

Full Information

First Posted
July 19, 2012
Last Updated
February 17, 2015
Sponsor
Lawson Health Research Institute
Collaborators
London Regional Cancer Program, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01647334
Brief Title
Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Official Title
Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
London Regional Cancer Program, Canada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shrinking Target Adaptive Radiotherapy
Arm Type
Experimental
Arm Description
Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Intervention Type
Radiation
Intervention Name(s)
Adaptive radiotherapy
Primary Outcome Measure Information:
Title
Tumor reduction
Time Frame
2.5 years (end of treatment)
Secondary Outcome Measure Information:
Title
Rate of tumor shrinkage
Time Frame
2.5 years (end of treatment)
Title
Change in lung dose
Time Frame
2.5 years (end of treatment)
Title
Delivered doses
Time Frame
2.5 years (end of treatment)
Title
Radiation pneumonitis rates
Time Frame
6 months, 12 months, 18 months, 24 months, 30 months (semi-annually)
Title
Local control
Time Frame
2.5 years (end of treatment)
Title
Overall survival
Time Frame
2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Palma, MD, PhD
Organizational Affiliation
London Regional Cancer Program of the Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Regional Cancer Program of the Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada

12. IPD Sharing Statement

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

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