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Phase I Dose Escalation Trial of Hypofractionated Limited-field External Beam Thoracic Radiotherapy for Limited Stage Small Cell Carcinoma of the Lung

Phase 1
18 Years
Not Enrolling
Lung Neoplasm, Small Cell Carcinoma

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Trial Information

Phase I Dose Escalation Trial of Hypofractionated Limited-field External Beam Thoracic Radiotherapy for Limited Stage Small Cell Carcinoma of the Lung

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.

Inclusion Criteria:

- patients with histologically or cytologically proven newly diagnosed small cell lung

- 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

- pregnancy (patients with childbearing potential must practice appropriate

- patients who have not had the pre-treatment evaluations outlined in the protocol

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rates of acute grade 3 or higher radiotherapy toxicities

Principal Investigator

Don Yee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services


Canada: Health Canada

Study ID:

LU-11-0072 / 23117



Start Date:

March 2007

Completion Date:

April 2011

Related Keywords:

  • Lung Neoplasm
  • Small Cell Carcinoma
  • small cell lung cancer
  • radiotherapy dose escalation
  • Neoplasms
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell