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A Clinical Trial of Increased Chest Radiotherapy Dose for Limited Stage Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Neoplasm, Small Cell Carcinoma

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Trial Information

A Clinical Trial of Increased Chest Radiotherapy Dose for Limited Stage Small Cell Lung Cancer


The ideal chest radiotherapy dose/fractionation scheme for limited stage small cell lung
cancer is undefined. Strategies of radiotherapy dose intensification with minimization of
overall treatment time are felt to improve cure rates for LS-SCLC. Hypofractionation (giving
higher than standard daily doses) facilitates both of these goals. In this study, we propose
to use a dose escalated hypofractionated regimen of chest radiotherapy for patients with
LS-SCLC.


Inclusion Criteria:



- limited stage small cell lung cancer

- adequate pulmonary function test (FEV1 >1.0 L, DLCO >50%)

- signed study consent

- age at least 18 years

- Karnofsky performance status as least 70%

- eligible to receive standard concurrent small cell cancer chemotherapy

Exclusion Criteria:

- extensive stage disease

- mixed non small cell and small cell histology

- inadequate pulmonary function tests

- not eligible for concurrent chemotherapy

- subtotal or total tumor resection

- previous chest/neck radiotherapy

- prior or concurrent malignancy except non-melanomatous skin unless disease free for
last 5 years

- pregnant

- prior chemotherapy for another malignancy

- patients with myocardial infarction within the preceding 6 months of symptomatic
heart disease, including, angina, congestive heart failure, uncontrolled arrhythmias

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2-year overall survival

Outcome Time Frame:

2011

Safety Issue:

No

Authority:

Canada: Ethics Review Committee

Study ID:

24762

NCT ID:

NCT00907569

Start Date:

June 2009

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

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