Clinical trial NCT01647334: 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
Overall status: TERMINATED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: London Regional Cancer Program, Canada
First posted: 2012-07-23
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Tumor reduction
timeFrame: 2.5 years (end of treatment)
Secondary outcomes:
measure: Rate of tumor shrinkage
timeFrame: 2.5 years (end of treatment)
measure: Change in lung dose
timeFrame: 2.5 years (end of treatment)
measure: Delivered doses
timeFrame: 2.5 years (end of treatment)
measure: Radiation pneumonitis rates
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months (semi-annually)
measure: Local control
timeFrame: 2.5 years (end of treatment)
measure: Overall survival
timeFrame: 2.5 years
Other outcomes:
Locations:
city: London
country: Canada
facility: London Regional Cancer Program of the Lawson Health Research Institute
state: Ontario
Study officials:
affiliation: London Regional Cancer Program of the Lawson Health Research Institute
name: David Palma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: