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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Lawson Health Research Institute
Sponsor:
Collaborator:
London Regional Cancer Program, Canada
Information provided by (Responsible Party):
David Palma, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01647334
First received: July 19, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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 Intervention
Non Small Cell Lung Cancer
Radiation: Adaptive radiotherapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Tumor reduction [ Time Frame: 2.5 years (end of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of tumor shrinkage [ Time Frame: 2.5 years (end of treatment) ] [ Designated as safety issue: No ]
  • Change in lung dose [ Time Frame: 2.5 years (end of treatment) ] [ Designated as safety issue: No ]
  • Delivered doses [ Time Frame: 2.5 years (end of treatment) ] [ Designated as safety issue: No ]
  • Radiation pneumonitis rates [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months (semi-annually) ] [ Designated as safety issue: Yes ]
  • Local control [ Time Frame: 2.5 years (end of treatment) ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 29
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Shrinking Target Adaptive Radiotherapy
Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Radiation: Adaptive radiotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647334

Contacts
Contact: David Palma, MD, PhD 519-685-8650 David.Palma@lhsc.on.ca

Locations
Canada, Ontario
London Regional Cancer Program of the Lawson Health Research Institute Recruiting
London, Ontario, Canada, N6A 4L6
Contact: David Palma, MD, PhD    519-685-8650    David.Palma@lhsc.on.ca   
Principal Investigator: David Palma, MD, PhD         
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
  More Information

No publications provided

Responsible Party: David Palma, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01647334     History of Changes
Other Study ID Numbers: Lung-START
Study First Received: July 19, 2012
Last Updated: May 8, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on November 20, 2014