Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels

Phase 2

Active, not recruiting

• Conditions: Cervix Neoplasms
• Interventions: Procedure: Pre-treatment tumour oxygen measurements (under anesthesia)

• Registration Number: NCT00188539
• Lead Sponsor: University Health Network, Toronto

Brief Summary

The aim of this study is to measure the oxygen content and interstitial fluid pressure in cervix cancer patients. Tumour oxygen content and internal pressure of tumours may be an important factor that influences the effectiveness of radiotherapy and other treatments.

Detailed Description

Not available

Study Timeline

• Study Start: 1995-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 300

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

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Exclusion Criteria

• Patients with clinically occult cervix carcinoma

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pre-treatment tumour oxygen measurements (under anesthesia)	Pre-treatment tumour oxygen measurements (under anesthesia)	-

Primary Outcome Measures

Name	Time	Method
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.	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
To correlate tumour IFP measured before and during radiation therapy with oxygen tension as measured by the Eppendorf probe and to assess IFP as a prognostic factor for pelvic control.	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

Secondary Outcome Measures

Name	Time	Method
To determine if whole cell or nuclear GSH levels are correlated with tumour oxygen tension and with tumour response and control.	follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada