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Hypofractionated Radiotherapy for Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by Alberta Cancer Board, May 2007
First Received: May 2, 2007   No Changes Posted
Sponsored by: Alberta Cancer Board
Information provided by: Alberta Cancer Board
ClinicalTrials.gov Identifier: NCT00469222
  Purpose

Current treatments for limited stage small cell lung cancer have poor cure rates. The addition of chest radiation to chemotherapy improves cure rates, but these cancers still come back in the chest 30-50% of the time. Two factors which can improve control and cure rates for this cancer are increasing the chest radiation dose and minimizing the overall time it takes to complete radiation treatments. One method to achieve both of these goals is to give more radiation each day. This study is meant to study how tolerable and effective it would be to increase the intensity of chest radiation for small cell lung cancer patients by increasing the daily radiation dose. We aim to find the highest dose of chest radiotherapy that can be safely given with chemotherapy using this strategy. Patients in this trial will be monitored before, during and after their radiation and chemotherapy treatments for treatment side-effects, how effective treatments are at controlling their cancer and quality of life changes. Results from this trial will help to define more effective radiotherapy doses which are tolerable for this type of lung cancer and the quality of life changes patients experience when they undergo these treatments.


Condition Intervention Phase
Lung Neoplasm
Small Cell Carcinoma
Procedure: hypofractionated external beam
Phase I

MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: Phase I Dose Escalation Trial of Hypofractionated Limited-Field External Beam Thoracic Radiotherapy for Limited Stage Small Cell Carcinoma of the Lung

Further study details as provided by Alberta Cancer Board:

Primary Outcome Measures:
  • Rates of acute grade 3 or higher radiotherapy toxicities

Secondary Outcome Measures:
  • Overall survival and disease free survival, patient related quality of life

Estimated Enrollment: 24
Study Start Date: March 2007
Detailed Description:

Local control and overall survival rates associated with the standard chemotherapy and radiotherapy given for limited stage small cell lung cancer are poor and emerging evidence from several studies suggests that intensifying the radiotherapy dose given may further improve patient outcomes, but at the cost of increased radiotherapy side effects. This proposal aims to study a novel method of intensifying chest radiotherapy dose via increasing the daily radiotherapy dose which is directed at regions of visible disease only. This strategy allows for delivery of increased radiation doses without prolonging overall treatment time and allowing potential regrowth of cancer cells. We aim to determine the maximum radiation dose which can be safely given with chemotherapy for limited stage small cell lung cancer and study the effects this type of radiation regimen with chemotherapy has on patient side effects and quality of life. Results from this trial will contribute to the development of the ideal radiotherapy regimen for limited stage small cell lung cancer. Our results will add to the literature studying the effects dose-intense radiation strategies for lung cancer have on patient quality of life.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with histologically or cytologically proven newly diagnosed small cell lung cancer
  • confirmation from the treating radiation oncologist that the patient has limited stage disease (i.e. disease that can be encompassed by radiotherapy portals without exposing patient to excessive risk of radiation lung injury)
  • adequate pulmonary function tests (FEV-1 >1.0, DLCO >50%)
  • patients of childbearing potential must practice adequate contraception
  • age greater than 18 years
  • Karnofsky performance status greater than 70
  • adequate hemotologic, hepatic and renal function: Hb>100g/L, WBC > 4.0x109/L, neutrophils > 1.0x109/L, platelets > 100,000x109/L, calculated GFR based on Cockcroft-Gault formula of >60mL/min (NOTE: for cisplatin, GFR must be above 60ml/min; if less than 60ml/min the patient can not receive cisplatin but could be considered for carboplatin)
  • patients must sign a study specific informed consent form

Exclusion Criteria:

  • patient who have undergone complete or subtotal tumour resection
  • evidence of non-small cell histology
  • pericardial or pleural effusion on radiologic investigations regardless of cytology
  • patients cannot be treated with 3DCRT with adherence to the dose volume constraints
  • prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for at least 5 years
  • prior radiotherapy to the thorax or neck
  • prior chemotherapy
  • patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure, uncontrolled arrhythmias
  • compromised lung function with inadequate pulmonary function tests (FEV-1<1.0, DLCO <50%)
  • pregnancy (patients with childbearing potential must practice appropriate contraception)
  • patients who have not had the pre-treatment evaluations outlined in the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469222

Contacts
Contact: Don Yee, MD 780-432-8783 donyee@cancerboard.ab.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Deanna Gilbert     780-432-8352     deannap@cancerboard.ab.ca    
Sub-Investigator: Wilson Roa, MD            
Sub-Investigator: Charles Butts, MD            
Sponsors and Collaborators
Alberta Cancer Board
Investigators
Principal Investigator: Don Yee, MD Alberta Cancer Board
  More Information

No publications provided

Study ID Numbers: LU-11-0072
Study First Received: May 2, 2007
Last Updated: May 2, 2007
ClinicalTrials.gov Identifier: NCT00469222     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by Alberta Cancer Board:
small cell lung cancer
radiotherapy dose escalation

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Carcinoma, Neuroendocrine
Neoplasms, Nerve Tissue
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Lung Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009