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A Study to See if a New Type of Imaging Can Help Our Understanding of the Course of Non-small Cell Lung Cancer in Patients Undergoing Treatment With Radiotherapy or Chemoradiotherapy


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Neoplasm, Cell Hypoxia

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Trial Information

A Study to See if a New Type of Imaging Can Help Our Understanding of the Course of Non-small Cell Lung Cancer in Patients Undergoing Treatment With Radiotherapy or Chemoradiotherapy


Locally advanced NSCLC has a poor prognosis with a 5 year overall survival rate of only 15%.
Tumour hypoxia may impact the ability to control NSCLC. Using 18F-FAZA PET, this study will
assess patients for hypoxic treatment. With this information, we can start individualizing
patient treatment to target hypoxia. The relationship between areas of hypoxia (18F-FAZA)
and high glucose utilization (18F-FDG) will also be assessed.


Inclusion Criteria:



1. Patients with histologically-proven, by biopsy or cytology, unresected lung cancer of
the following histological types: squamous cell carcinoma; adenocarcinoma;
undifferentiated large cell carcinoma, and non-small cell, not otherwise specified
(NOS, diagnosis on cytology alone)

2. Patients with American Joint Committee on Cancer (AJCC) Stage I, II, IIIA, or IIIB
with detectable tumour that can be encompassed by radiation therapy fields, including
both primary tumour and the involved regional lymph nodes.

3. Patients must be deemed to be suitable to undergo definitive (i.e. potentially
curable) chemoradiotherapy or radiotherapy by the treating Physician.

4. The prescribed radiotherapy dose must be a minimum of 60 Gy in 30 fractions

5. Male or female ≥ 18 years of age. If female of child bearing potential and outside
the window of 10 days since the first day of the last menstrual period, a negative
pregnancy test is required.

6. ECOG/Zubrod status 0-1

7. Patients must have at least one measurable lesion ≥ 1 cm on CT

8. Able and willing to follow instructions and comply with the protocol

9. Provide written informed consent prior to participation in the study

Exclusion Criteria:

1. Patients who have undergone complete or subtotal tumour resection

2. Patients with post-resection intrathoracic tumour recurrence

3. Patients eligible for definitive surgery (patients who are eligible for surgery, but
surgery did not proceed are eligible for this trial)

4. No distant or metastasis, prior chemotherapy, or thoracic neck or radiotherapy

5. Evidence of any small cell histology

6. Prior or concurrent malignancy (except non-melanomatous skin cancer) unless
disease-free for at least 5 years

7. Inability to lay in supine position for approximately one hour

8. Nursing or pregnant females

9. Aged less than 18 years

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To determine the relationship between hypoxic changes and the early local tumour response after definitive radiotherapy or chemoradiotherapy in NSCLC

Outcome Time Frame:

2.5 yrs

Safety Issue:

No

Principal Investigator

Dr. Wilson Roa, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

wilsonro@cancerboard.ab.ca

Authority:

Canada: Health Canada

Study ID:

LU-24319

NCT ID:

NCT00765986

Start Date:

October 2008

Completion Date:

October 2012

Related Keywords:

  • Lung Neoplasm
  • Cell Hypoxia
  • 18F-FAZA
  • 18F-FDG
  • Positron Emission Tomography
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Anoxia

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