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Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NCIC Clinical Trials Group
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188539
First received: September 12, 2005
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Cervix Neoplasms
Procedure: Pre-treatment tumour oxygen measurements (under anesthesia)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and GSH Levels

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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. [ 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 ] [ Designated as safety issue: No ]
  • 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. [ 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if whole cell or nuclear GSH levels are correlated with tumour oxygen tension and with tumour response and control. [ Time Frame: follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 1995
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pre-treatment tumour oxygen measurements (under anesthesia) Procedure: Pre-treatment tumour oxygen measurements (under anesthesia)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188539

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
NCIC Clinical Trials Group
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Anthony Fyles, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188539     History of Changes
Other Study ID Numbers: UHN REB 01-0376-C, National Cancer Inst of Canada
Study First Received: September 12, 2005
Last Updated: June 2, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014