Pilot Study of 18F-FAZA in Assessing Early Functional Response in Patients With Inoperable Non Small Cell Lung Cancer Undergoing Radiotherapy or Chemo-radiotherapy

NCT00765986 | Unknown

• 1 other identifier: LU-24319
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Neoplasm; Cell Hypoxia

Keywords

18F-FAZA; 18F-FDG; Positron Emission Tomography

Outcome Measures

Primary Outcomes (1)

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

  2.5 yrs

Secondary Outcomes (2)

• To establish if a correlation exists between 18F-FAZA PET and FluGlucoScan Injection PET in determining responses to definitive treatment in NSCLC

  2.5 yrs

• To assess if patterns of local failure/overall survival correlate with 18F-FAZA PET and/or FluGlucoScan Injection PET

  7 yrs

Study Arms (1)

1

Patients with inoperable NSCLC undergoing RT or Chemo-RT

Other: 18F-FAZA; Other: 18F-Fluorodeoxyglucose (18F-FDG)

Interventions

18F-FAZA OTHER

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.

Also known as: NAP

1

18F-Fluorodeoxyglucose (18F-FDG) OTHER

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.

Also known as: FluGlucoScan Injection

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with inoperable NSCLC undergoing radiotherapy or chemoradiotherapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, Canada

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

fluoroazomycin arabinoside; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Dr. Wilson Roa, MD

  wilson.roa@albertahealthservices.ca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lai Schrader

CONTACT

780.432.8464; Lai.Schrader@albertahealthservices.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 3, 2014

Record last verified: 2014-10

Locations

CA (1)