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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how oxygen levels and fluid pressure in cervical cancer tumors might influence treatment success, particularly with radiotherapy. Researchers aim to determine if these factors affect treatment efficacy. Participants will undergo pre-treatment tumor oxygen measurements. This trial is suitable for individuals newly diagnosed with cervical cancer, where the tumor measures 3 cm or larger, and staging includes an exam under anesthesia. As a Phase 2 trial, this research focuses on assessing treatment effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant findings in cervical cancer treatment.

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 prior data suggests that pre-treatment tumour oxygen measurements are safe for cervical cancer patients?

Research has shown that checking oxygen levels in tumors is generally safe for patients. In one study, 83% of cases showed a strong response when extra oxygen was added, indicating that the method works well and is easy for patients to handle. The study primarily assessed the technique's practicality and found no major safety issues. This suggests the process is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pre-treatment tumor oxygen measurements for cervical cancer because it offers a new way to understand the tumor environment before starting standard treatments like chemotherapy and radiation. Unlike traditional approaches that focus on directly attacking cancer cells, this method measures the oxygen levels in tumors while the patient is under anesthesia. This could provide insights into how tumors might respond to treatment, potentially allowing for more personalized and effective therapy plans. By tailoring treatment strategies based on these measurements, doctors might improve patient outcomes and minimize unnecessary side effects.

What evidence suggests that pre-treatment tumour oxygen measurements are effective for cervical cancer?

Research shows that low oxygen levels in cervical tumors can lead to worse outcomes, such as cancer spreading and treatments being less effective. Studies have found that tumors with more oxygen respond better to treatments. For example, patients with well-oxygenated tumors have a 71% chance of the cancer not worsening, compared to just 28% for those with low oxygen levels. This trial will measure tumor oxygen levels under anesthesia before treatment to help predict therapy response. Understanding tumor oxygen levels could be crucial for improving treatment success. ^{4 6 7 8 9}

Who Is on the Research Team?

Anthony Fyles, MD

Principal Investigator

Princess Margaret Hospital, Canada

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301698003071

Cervix cancer oxygenation measured following external ... Conclusions: Unlike pretreatment results, tumour oxygenation measured following external radiation does not appear to be a useful predictive assay in patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7336054/

The clinical utility of imaging methods used to measure ... While it is well-established that hypoxia is a major factor that affects clinical outcomes in cervical cancer, widespread usage of clinically available methods ...

3. international-journal-of-gynecological-cancer.com international-journal-of-gynecological-cancer.com/article/S1048-891X(24)02139-X/fulltext

Impact of hypoxia on cervical cancer outcomes Low tumorous oxygenation increases the risk of local invasion, metastasis and treatment failure. While meta-analyses show benefit, many individual trials ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/49/2/201

Assessing Tumor Hypoxia in Cervical Cancer by PET with 60 ... The 3-y progression-free survival of patients with normoxic tumors (T/M of ≤3.5) was 71%, and that of patients with hypoxic tumors (T/M of >3.5) was 28% (P = ...

5. aacrjournals.org aacrjournals.org/clincancerres/article/12/7/2185/284996/Carbon-Beam-Therapy-Overcomes-the-Radiation

Carbon Beam Therapy Overcomes the Radiation Resistance ... The local control rates of hypoxic and oxygenated tumors before treatment were 58% and 54%, respectively. The disease-free survival rates of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11090266/

Promising predictive molecular biomarkers for cervical ... These results show that increased SCC-Ag levels before treatment could be useful in predicting treatment failure and selecting adjuvant therapies, such as ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00188539

Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels | ... The aim of this study is to measure the oxygen content and interstitial fluid pressure in cervix cancer patients. ... Pre-treatment tumour oxygen measurements ( ...

8. researchgate.net researchgate.net/publication/355014297_First-In-Human_Study_in_Cancer_Patients_Establishing_the_Feasibility_of_Oxygen_Measurements_in_Tumors_Using_Electron_Paramagnetic_Resonance_With_the_OxyChip

(PDF) First-In-Human Study in Cancer Patients ... In 83% of the measurements, there was a statistically significant (p ≤ 0.05) response to hyperoxygenation. Conclusions Measurement of baseline ...

9. aacrjournals.org aacrjournals.org/cancerres/article/61/17/6400/507810/Interstitial-Fluid-Pressure-Predicts-Survival-in

Interstitial Fluid Pressure Predicts Survival in Patients with ... Interstitial fluid pressure predicts survival in patients with cervix cancer independent of clinical prognostic factors and tumor oxygen measurements.