Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung Cancer

NCT01426841 | Unknown Phase 1 DMC

• 1 other identifier: CCI Yee 25708
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Small cell lung cancer; Adaptive radiotherapy; Thoracic radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Local control and patterns of failure

  12-24 months

• Survival

  12-24 months

Interventions

Adaptive Radiation RADIATION

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

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

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

• Don Yee, MD, FRCPC

  Cross Cancer Institute, Alberta Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: September 1, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 2, 2014

Record last verified: 2014-10

Locations

CA (1)