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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00643396
Enrollment
30
Registered
2008-03-26
Start date
2008-02-29
Completion date
2012-01-31
Last updated
2016-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extensive Stage Small Cel Lung Cancer

Keywords

small cell lung cancer, radiotherapy

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.

Interventions

RADIATIONthoracic radiotherapy

Sponsors

Cross Cancer Institute
CollaboratorOTHER
AHS Cancer Control Alberta
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
radiotherapy toxicities1-2 years after study treatment
patient quality of life1-2 years after study treatment
overall survival1-2 years after study treatment

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026