Pilot Study of 18F-FAZA in Assessing Early Functional Response in Patients With Inoperable Non Small Cell Lung Cancer Undergoing RT/ChemoRT - Full Text View

Sponsored by:	Alberta Cancer Board
Information provided by:	Alberta Cancer Board
ClinicalTrials.gov Identifier:	NCT00765986

Purpose

Non-small cell lung cancer (NSCLC) has a poor prognosis if not caught early enough. One of the factors that may impact the ability to control NSCLC is low oxygen levels (hypoxia) inside the tumour. This study will use 18F-FAZA PET scans to assess whether patients have hypoxic tumours and to monitor the changes to the hypoxic areas of a tumour during currently available standard treatment. It is hypothesized that 18F-FAZA PET may predict response to treatment, local control, and/or survival in NSCLC.

Condition	Intervention
Lung Neoplasm Cell Hypoxia	Other: 18F-FAZA Other: 18F-Flurodeoxyglucose (18F-FDG)

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Fluorodeoxyglucose F18

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	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

Further study details as provided by Alberta Cancer Board:

Primary Outcome Measures:

To determine the relationship between hypoxic changes and the early local tumour response after definitive radiotherapy or chemoradiotherapy in NSCLC [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To establish if a correlation exists between 18F-FAZA PET and FluGlucoScan Injection PET in determining responses to definitive treatment in NSCLC [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]
To assess if patterns of local failure/overall survival correlate with 18F-FAZA PET and/or FluGlucoScan Injection PET [ Time Frame: 7 yrs ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	November 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with inoperable NSCLC undergoing RT or Chemo-RT	Other: 18F-FAZA Radioactive dose of 110-600 MBq per injection. Up to a maximum of 6 injections per patient: pre-Tx, after 4 weeks (20 fractions) of RT, then 4 weeks, 90 days and 12 months post-RT and upon logo-regional progression or recurrence. Other: 18F-Flurodeoxyglucose (18F-FDG) Radioactive dose of 100-710 MBq per injection. Up to a maximum of 6 injections per patient: pre-Tx, after 4 weeks (20 fractions) RT, then 4 weeks, 90 days, and 12 months post-RT, and upon loco-regional progression or recurrence.

Groups/Cohorts

Assigned Interventions

1

Patients with inoperable NSCLC undergoing RT or Chemo-RT

Other: 18F-FAZA

Radioactive dose of 110-600 MBq per injection. Up to a maximum of 6 injections per patient: pre-Tx, after 4 weeks (20 fractions) of RT, then 4 weeks, 90 days and 12 months post-RT and upon logo-regional progression or recurrence.

Other: 18F-Flurodeoxyglucose (18F-FDG)

Radioactive dose of 100-710 MBq per injection. Up to a maximum of 6 injections per patient: pre-Tx, after 4 weeks (20 fractions) RT, then 4 weeks, 90 days, and 12 months post-RT, and upon loco-regional progression or recurrence.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with inoperable NSCLC undergoing radiotherapy or chemoradiotherapy

Criteria

Inclusion Criteria:

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)
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.
Patients must be deemed to be suitable to undergo definitive (i.e. potentially curable) chemoradiotherapy or radiotherapy by the treating Physician.
The prescribed radiotherapy dose must be a minimum of 60 Gy in 30 fractions
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.
ECOG/Zubrod status 0-1
Patients must have at least one measurable lesion ≥ 1 cm on CT
Able and willing to follow instructions and comply with the protocol
Provide written informed consent prior to participation in the study

Exclusion Criteria:

Patients who have undergone complete or subtotal tumour resection
Patients with post-resection intrathoracic tumour recurrence
Patients eligible for definitive surgery (patients who are eligible for surgery, but surgery did not proceed are eligible for this trial)
No distant or metastasis, prior chemotherapy, or thoracic neck or radiotherapy
Evidence of any small cell histology
Prior or concurrent malignancy (except non-melanomatous skin cancer) unless disease-free for at least 5 years
Inability to lay in supine position for approximately one hour
Nursing or pregnant females
Aged less than 18 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765986

Contacts

Contact: Lai Schrader

780.432.8464

liaschra@cancerboard.ab.ca

Locations

Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada

Sponsors and Collaborators

Alberta Cancer Board

Investigators

Principal Investigator:

Dr. Wilson Roa, MD

wilsonro@cancerboard.ab.ca

More Information

Study ID Numbers:	LU-24328
Study First Received:	October 2, 2008
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00765986
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Cancer Board:

18F-FAZA
18F-FDG
Positron Emission Tomography

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 13, 2009