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Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and GSH Levels


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Cervix Neoplasms

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Trial Information

Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and GSH Levels


Inclusion Criteria:



- Newly diagnosed patients with carcinoma of the cervix ( 3 cm in size or larger) where
an examination under anesthesia is to be performed for staging purposes

- Informed consent

Exclusion Criteria:

- Patients with clinically occult cervix carcinoma

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To determine if tumour oxygen tension prior to and during radiation therapy is an independent prognostic factor for primary tumour response and control in patients with cervix cancer.

Outcome Time Frame:

tumour measurement will be done 2-3 months following completion of treatment; follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter

Safety Issue:

No

Principal Investigator

Anthony Fyles, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Ethics Review Committee

Study ID:

UHN REB 01-0376-C

NCT ID:

NCT00188539

Start Date:

December 1995

Completion Date:

December 2013

Related Keywords:

  • Cervix Neoplasms
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Anoxia

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