Brachytherapy for Cervical Cancer

Overseen By Jillian Skerchak

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Disqualifiers: Pregnant, Breast-feeding, Prior pelvic radiation, others

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

Duration: Up to 8 months

41 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a shorter, 3-session brachytherapy (a type of internal radiation treatment) is as effective as the standard 4-session treatment for women with locally advanced cervical cancer. Researchers aim to determine if fewer sessions can maintain the same powerful effects against the cancer while offering more convenience for patients. Women diagnosed with cervical cancer and planning to receive brachytherapy might be suitable candidates for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that 3-fraction HDR brachytherapy is generally manageable for patients. Most studies suggest this treatment is a good option for those with locally advanced cervical cancer. Importantly, serious side effects, such as stomach and urinary issues, occur in less than 10% of cases, indicating the treatment's safety.

In contrast, 4-fraction HDR brachytherapy is already a common treatment. It has been widely used and is known to be safe. Overall, both treatments are safe, with the 3-fraction method showing similar promising results to the traditional 4-fraction approach. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the 3-Fraction HDR Brachytherapy for cervical cancer because it offers a potentially more efficient treatment option compared to the traditional 4-Fraction regimen. This investigational approach delivers a total dose of 24 Gy in just three sessions, which could reduce the time patients spend undergoing therapy. Additionally, this method aims to maintain effective cancer control while adhering to safety constraints for surrounding organs, which may enhance patient convenience without compromising treatment effectiveness.

What evidence suggests that this trial's treatments could be effective for cervical cancer?

This trial will compare two different brachytherapy regimens for cervical cancer. Research has shown that a 3-session high-dose-rate (HDR) brachytherapy treatment, which participants in one arm of this trial may receive, is promising. Studies have found that patients who received this treatment achieved similar cancer control and survival rates compared to standard treatments. They also experienced similar side effects, with some studies suggesting less urinary discomfort. The 3-session approach is generally well-tolerated and might serve as a good alternative to the traditional 4-session treatment, which is being tested in another arm of this trial. This suggests it could be just as effective while possibly reducing the number of treatment visits. ^{1 3 6 7 8}

Who Is on the Research Team?

Elizabeth Kidd, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with cervical cancer who need brachytherapy, a type of internal radiation treatment. They should be relatively active and able to care for themselves (ECOG status 0-2) and must understand the study enough to give written consent.

Inclusion Criteria

I am 18 years old or older.

I can care for myself and am up and about more than 50% of my waking hours.

I can understand and am willing to sign the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a 3-fraction or 4-fraction high dose rate brachytherapy regimen

Up to 8 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3-Fraction HDR Brachytherapy
• 4-Fraction HDR Brachytherapy

Trial Overview The study is testing two different brachytherapy schedules in patients with advanced cervical cancer: one group will receive the standard four treatments, while another group will get three treatments to see if it's just as effective.

How Is the Trial Designed?

Group I: 3-Fraction Brachytherapy Arm Experimental Treatment 1 Intervention

Patients who meet dosimetric criteria at the first brachytherapy session (HR CTV D90 \> 85 Gy and acceptable OAR constraints) will receive an investigational 3-fraction HDR brachytherapy regimen (24 Gy total).

Group II: Investigational Treatment Active Control 1 Intervention

Patients who do not meet dosimetric criteria for the investigational regimen will receive the institutional standard-of-care regimen of 4 fractions (28 Gy total).

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. brachyjournal.com brachyjournal.com/article/S1538-4721(24)00453-7/fulltext

Clinical and dosimetric outcomes of a 3-fraction high-dose ... Three-fraction HDR brachytherapy boost was generally well-tolerated by patients and may be a viable alternative in the treatment of LACC.

2. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(25)00743-7/fulltext

Outcomes of a 3-fraction brachytherapy protocol for ... In this cohort receiving a 3-fraction brachytherapy protocol, local control, DFS and OS outcomes were comparable to historical controls adjusted for stage.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0360301624007454

Clinical Outcomes of 3 Versus 4 Fractions of Magnetic ... Patients with cervical cancer treated with 24 Gy/3 Fr had similar DFS, LF, DF, GI, and vaginal toxicity rates and a trend toward a lower G2+ urinary toxicity ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36631374/

Outcomes from a 3-fraction high-dose-rate brachytherapy ... Conclusions: Local control was excellent, with long term survival and toxicity similar between the groups. These findings support consideration of 3F. Keywords: ...

5. redjournal.org redjournal.org/article/S0360-3016(24)00745-4/pdf

Clinical Outcomes of 3 Versus 4 Fractions of Magnetic ... 011. brachytherapy fractionation schedule of 24 Gy/3 Fr is a safe alternative to 28 Gy/4 Fr for definitive treatment of cervical cancer.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1538472124004537

Clinical and dosimetric outcomes of a 3-fraction high-dose ... Three-fraction HDR brachytherapy boost was generally well-tolerated by patients and may be a viable alternative in the treatment of LACC.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39645406/

Clinical and dosimetric outcomes of a 3-fraction high-dose ... Conclusions: Three-fraction HDR brachytherapy boost was generally well-tolerated by patients and may be a viable alternative in the treatment of LACC.

8. redjournal.org redjournal.org/article/S0360-3016(24)00745-4/fulltext

Clinical Outcomes of 3 Versus 4 Fractions of Magnetic ... Patients with cervical cancer treated with 24 Gy/3 Fr had similar DFS, LF, DF, GI, and vaginal toxicity rates and a trend toward a lower G2+ ...