Oxygen and Fluid Pressure Measurements for Cervical Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Disqualifiers: Occult cervix carcinoma

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Pre-treatment tumour oxygen measurements for cervical cancer?

Research shows that measuring tumor oxygen levels can help predict survival rates in cervical cancer patients. Tumors with lower oxygen levels tend to have worse outcomes, suggesting that knowing a tumor's oxygen level before treatment can be important for understanding a patient's prognosis. ^{1 2 3 4 5}

Is it safe to measure oxygen and fluid pressure in cervical cancer patients?

The studies show that measuring oxygen levels and fluid pressure in cervical cancer patients is generally safe, with no adverse effects reported during the procedures. ^{2 5 6 7 8}

How does the treatment involving oxygen and fluid pressure measurements differ from other treatments for cervical cancer?

This treatment is unique because it focuses on measuring the oxygen levels within the tumor, which can predict the tumor's behavior and response to treatments like radiation. Unlike traditional therapies that directly target the cancer cells, this approach provides valuable information about the tumor's environment, potentially guiding more effective treatment strategies. ^{2 9 10 11 12}

Research Team

Anthony Fyles, MD

Principal Investigator

Princess Margaret Hospital, Canada

Eligibility Criteria

This trial is for individuals newly diagnosed with cervical cancer, specifically those with tumors 3 cm or larger. Participants must be undergoing an examination under anesthesia for staging and must provide informed consent to partake in the study.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment Assessment

Measurement of tumour oxygen content and interstitial fluid pressure under anesthesia

Treatment

Participants receive radiotherapy and other treatments as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Pre-treatment tumour oxygen measurements

Trial Overview The study aims to measure oxygen levels and interstitial fluid pressure inside cervical cancer tumors. These measurements are taken before any treatment starts, as they may affect how well radiotherapy and other treatments work.

Participant Groups

Group I: Pre-treatment tumour oxygen measurements (under anesthesia) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Canadian Cancer Trials Group

Collaborator

Trials

135

Recruited

70,300+

Princess Margaret Hospital, Canada

Collaborator

Trials

121

Recruited

40,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Tumor size and oxygenation are independent predictors of nodal diseases in patients with cervix cancer. [2019]

2. Ireland pubmed.ncbi.nlm.nih.gov

Intratumoral pO2 predicts survival in advanced cancer of the uterine cervix. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Association between tumor hypoxia and malignant progression in advanced cancer of the uterine cervix. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Intratumor pO2, S-phase fraction and p53 status in cervix carcinomas]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Oxygenation of carcinomas of the uterine cervix: evaluation by computerized O2 tension measurements. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Feasibility of measuring oxygen tension in uterine cervix carcinoma. [2019]

7. Ireland pubmed.ncbi.nlm.nih.gov

Intratumoral pO2-measurements as predictive assay in the treatment of carcinoma of the uterine cervix. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Interstitial hypertension in carcinoma of uterine cervix in patients: possible correlation with tumor oxygenation and radiation response. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Determination of local oxygen consumption rates in tumors. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

Noninvasive measurement of microvascular and interstitial oxygen profiles in a human tumor in SCID mice. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Measurements of partial oxygen pressure pO2 using the OxyLite system in R3327-AT tumors under isoflurane anesthesia. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

A comparison in individual murine tumors of techniques for measuring oxygen levels. [2019]