Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer

NCT ID: NCT01426841

Last Updated: 2014-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2015-04-30

Brief Summary

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.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Adaptive Radiation

Thoracic Radiotherapy which is adapted or adjusted during its course to account for tumor volume shrinkage which occurs during treatment

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Don Yee, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Cross Cancer Institute, Alberta Health Services

Locations

Cross Cancer Institute

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

CCI Yee 25708

Identifier Type: -

Identifier Source: org_study_id