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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01647334
Other study ID # Lung-START
Secondary ID
Status Terminated
Phase N/A
First received July 19, 2012
Last updated February 17, 2015
Start date January 2013
Est. completion date December 2014

Study information

Verified date February 2015
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 29
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Radiation:
Adaptive radiotherapy


Locations

Country Name City State
Canada London Regional Cancer Program of the Lawson Health Research Institute London Ontario

Sponsors (2)

Lead Sponsor Collaborator
Lawson Health Research Institute London Regional Cancer Program, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor reduction 2.5 years (end of treatment) No
Secondary Rate of tumor shrinkage 2.5 years (end of treatment) No
Secondary Change in lung dose 2.5 years (end of treatment) No
Secondary Delivered doses 2.5 years (end of treatment) No
Secondary Radiation pneumonitis rates 6 months, 12 months, 18 months, 24 months, 30 months (semi-annually) Yes
Secondary Local control 2.5 years (end of treatment) No
Secondary Overall survival 2.5 years No
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