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

Lung Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00765986
• Other study ID #: LU-24319
• Status: Recruiting
• Phase: N/A
• First received: October 2, 2008
• Last updated: October 2, 2014
• Start date: October 2008
• Est. completion date: October 2015

Study information

• Verified date: October 2014
• Source: AHS Cancer Control Alberta
• Contact: Lai Schrader
• Phone: 780.432.8464
• Email: Lai.Schrader[@]albertahealthservices.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Cell Hypoxia
• Lung Neoplasm
• Lung Neoplasms

Intervention

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.
• 18F-Fluorodeoxyglucose (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.

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the relationship between hypoxic changes and the early local tumour response after definitive radiotherapy or chemoradiotherapy in NSCLC		2.5 yrs	No
Secondary	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	No
Secondary	To assess if patterns of local failure/overall survival correlate with 18F-FAZA PET and/or FluGlucoScan Injection PET		7 yrs	No