Hypofractionated Radiotherapy for Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00469222
First received: May 2, 2007
Last updated: March 19, 2012
Last verified: March 2012
  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 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Dose Escalation Trial of Hypofractionated Limited-field External Beam Thoracic Radiotherapy for Limited Stage Small Cell Carcinoma of the Lung

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

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

Enrollment: 24
Study Start Date: March 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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 hematologic, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469222

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Don Yee, MD AHS Cancer Control Alberta
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00469222     History of Changes
Other Study ID Numbers: LU-11-0072 / 23117
Study First Received: May 2, 2007
Last Updated: March 19, 2012
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Carcinoma
Small Cell Lung Carcinoma
Lung Neoplasms
Carcinoma, Small Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014