Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer

This study is intended to assess the feasibility of adjusting a radiation plan during its course to accommodate for a shrinking tumor target. The investigators hypothesize that an adaptive radiotherapy (RT) planning strategy for small cell lung cancer (SCLC) patients with chest-confined disease will allow for safe delivery of higher doses of chest RT than a non-adaptive RT planning approach without subjecting normal critical structures to unacceptable doses of radiotherapy.

Study Overview

• Status: Unknown
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Radiation: Adaptive Radiation

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with histologically or cytologically proven newly diagnosed small cell lung cancer
• chest-confined disease (including bulky intrathoracic disease)
• adequate pulmonary function tests (FEV-1>1.0 L, DLCO>50%)
• patients of childbearing potential must practice adequate contraception
• Age > or = 18 years
• Karnofsky performance status > or = 70
• eligible for concurrent chemoradiotherapy

Exclusion Criteria:

• patients who have undergone complete or subtotal tumour resection
• evidence of non-small cell histology
• prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
• prior RT to the thorax or neck
• compromised lung function with inadequate pulmonary function tests (FEV-1<1.0,DLCO<50%)
• pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach	Differences in normal structure/target volume doses achievable using adaptive radiotherapy approach will be measured in centigray	12-24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local control and patterns of failure	Local control and patterns of failure	12-24 months
Survival		12-24 months

Collaborators and Investigators

• Sponsor: AHS Cancer Control Alberta
• Investigators: Principal Investigator: Don Yee, MD, FRCPC, Cross Cancer Institute, Alberta Health Services

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): April 1, 2015

Study Registration Dates

• First Submitted: April 15, 2011
• First Submitted That Met QC Criteria: August 31, 2011
• First Posted (Estimate): September 1, 2011

Study Record Updates

• Last Update Posted (Estimate): October 2, 2014
• Last Update Submitted That Met QC Criteria: October 1, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Small cell lung cancer; Adaptive radiotherapy; Thoracic radiotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: CCI Yee 25708