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

NCT01647334 | Terminated DMC

• 1 other identifier: Lung-START
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor reduction

  2.5 years (end of treatment)

Secondary Outcomes (6)

• 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)

Study Arms (1)

Shrinking Target Adaptive Radiotherapy

EXPERIMENTAL

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

Radiation: Adaptive radiotherapy

Interventions

Adaptive radiotherapy RADIATION

Shrinking Target Adaptive Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• London Regional Cancer Program, Canada: collaborator

Study Sites (1)

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, N6A 4L6, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• David Palma, MD, PhD

  London Regional Cancer Program of the Lawson Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 23, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 19, 2015

Record last verified: 2015-02

Locations

CA (1)