Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer

NCT00643396 | Completed Phase 2

• 1 other identifier: LU-23929/23929
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The majority of patients with small cell lung cancer have incurable extensive stage disease. The usual initial treatment for this condition is chemotherapy which produces responses in about 50-80% of patients. Despite this, the cancer usually returns. Once common body region where it re-grows is in the chest, which can cause symptoms such as shortness of breath, cough, difficulty swallowing, pain and bleeding. These symptoms can worsen a patient's quality of life and in some situation be life-threatening. In this study , we propose to give patients who have extensive stage small cell lung cancer which responds to chemotherapy radiotherapy treatments to the chest. By giving this type of radiation before the cancer has a chance to re-grow, we hope to control the disease within the chest and prevent future symptoms that it may cause if the cancer were to re-grow in the chest. Patients treated on the protocol will be checked regularly for disease control, quality of life and radiation side effects, if any.

Conditions

Extensive Stage Small Cel Lung Cancer

Keywords

small cell lung cancer; radiotherapy

Outcome Measures

Primary Outcomes (1)

• local control

  we anticipate completing accrual to the study in 12 months with most local failure events occuring within 2 years of treatment

Secondary Outcomes (3)

• radiotherapy toxicities

  1-2 years after study treatment

• patient quality of life

  1-2 years after study treatment

• overall survival

  1-2 years after study treatment

Interventions

thoracic radiotherapy RADIATION

Eligibility Criteria

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

You may qualify if:

• Histologic or cytologic confirmation of small cell lung cancer
• extensive stage disease
• adequate pulmonary function tests (FEV-1\>1.0, DLCO\>50%)
• patients of childbearing potential must practice adequate contraception
• age ≧ 18 years
• Karnofsky performance status ≧ 70
• documented objective response to initial chemotherapy
• signed study-specific informed consent form

You may not qualify if:

• complete or subtotal tumor resection
• non-small cell histology
• prior or concurrent malignancy except non-melanoma skin cancer unless disease-free for at least 5 years
• prior chest or neck RT
• inadequate pulmonary function tests (FEV-1\<1.0 OR DLCO\<50%)
• pregnant

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Cross Cancer Institute: collaborator

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

  AHS Cancer Control Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 26, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 26, 2016

Record last verified: 2012-04

Locations

CA (1)