Clinical trial NCT01181375: Predictive Assays In Cervix Cancer
Official title: Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and Tissue and Plasma Biomarkers of Hypoxia (CXTF10)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical cancer
assay
hypoxia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-08-13
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The experiments outlined in this proposal will compare a number of currently available techniques for assessing hypoxia and interstitial fluid pressures in patients with cervix cancer. The aim of these experiments is to establish the relationship of the clinically relevant outcome measures of tumour control and survival following radiation therapy with these biological characteristics of carcinoma of the cervix relevant to tumour hypoxia. These characteristics will be assessed in patients undergoing treatment using techniques which have reached an appropriate level of development for clinical evaluation and aim to determine the best technique for determining these parameters of the tumour microenvironment. A number of novel strategies directed at the microenvironment are undergoing or soon will be undergoing clinical evaluation and selection of appropriate patients for these trials is of great importance.


Eligibility criteria: Inclusion Criteria:

1. Histologic diagnosis of cervix cancer
2. A decision to treat using radiation therapy according to the existing treatment policies of the PMH Gynecology Group
3. Clinical stage IB-IV with grossly evident cervical disease
4. No distant metastases
5. No cytotoxic anti-cancer therapy for cervical carcinoma prior to study entry
6. Signed informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: To understand the mechanisms by which hypoxia and IFP influence disease progression, and response to radiotherapy, chemotherapy and other novel biologically-targeted therapies in patients with cervix cancer.
timeFrame: 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.
Secondary outcomes:
measure: To determine if tissue biomarkers of hypoxia are independent prognostic factors for relapse and survival in patients with cervix cancer.
timeFrame: 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.
measure: To determine if plasma biomarkers of hypoxia are independent prognostic factors for relapse and survival in patients with cervix cancer.
timeFrame: 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.
measure: To assess the heterogeneity of tissue biomarkers of hypoxia in multiple biopsies from cervix cancers.
timeFrame: 3 months during the first two years, every 4-6 months during years 3 to 5 and yearly thereafter.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Princess Margaret Hospital
name: Anthony Fyles, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Princess Margaret Hospital
name: Michael Milosevic, MD
role: PRINCIPAL_INVESTIGATOR
References: