ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01647334
Recruitment Status : Terminated (Poor accrual)
First Posted : July 23, 2012
Last Update Posted : February 19, 2015
Sponsor:
Collaborator:
London Regional Cancer Program, Canada
Information provided by (Responsible Party):
David Palma, 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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Radiation: Adaptive radiotherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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



Primary Outcome Measures :
  1. Tumor reduction [ Time Frame: 2.5 years (end of treatment) ]

Secondary Outcome Measures :
  1. Rate of tumor shrinkage [ Time Frame: 2.5 years (end of treatment) ]
  2. Change in lung dose [ Time Frame: 2.5 years (end of treatment) ]
  3. Delivered doses [ Time Frame: 2.5 years (end of treatment) ]
  4. Radiation pneumonitis rates [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months (semi-annually) ]
  5. Local control [ Time Frame: 2.5 years (end of treatment) ]
  6. Overall survival [ Time Frame: 2.5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647334


Locations
Canada, Ontario
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada, N6A 4L6
Sponsors and Collaborators
Lawson Health Research Institute
London Regional Cancer Program, Canada
Investigators
Principal Investigator: David Palma, MD, PhD London Regional Cancer Program of the Lawson Health Research Institute

Responsible Party: David Palma, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01647334     History of Changes
Other Study ID Numbers: Lung-START
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: February 19, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms