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

NCT01647334 — Not applicable, Terminated, 29 participants, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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Registry	NCT01647334
Status	Terminated - Poor accrual
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	29 (Estimated)
Sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (Other); collaborators: London Regional Cancer Program, Canada
Conditions	Non Small Cell Lung Cancer
Interventions	Adaptive radiotherapy (Radiation)
Dates	start 2013-01-01, primary completion 2014-12-01, completion 2014-12-01, first posted 2012-07-23, last updated 2015-02-19
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Shrinking Target Adaptive Radiotherapy	Experimental	Radiation: Adaptive radiotherapy	Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer

Adaptive radiotherapy (Radiation)

+Outcome measures

Primary outcomes

Tumor reduction [2.5 years (end of treatment)]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
London Regional Cancer Program of the Lawson Health Research Institute	London, Ontario	Canada

+Investigators

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