116 Participants NeededMy employer runs this trial

Photon vs Proton Radiation for Gynecologic Cancers

Recruiting at 4 trial locations
EN
CE
Overseen ByCaitlin Eggleston, MPH
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: University of Maryland, Baltimore
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two types of radiation treatments for endometrial and cervical cancer to determine which causes fewer side effects. Participants will receive either photon radiation or proton radiation, specifically Intensity Modulated Proton Therapy (IMPT), both common treatments. It suits women recently diagnosed with endometrial or cervical cancer who plan to undergo chemotherapy and radiation. Those who have had surgery, chemotherapy, or pelvic radiation before may not find this trial suitable. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in cancer care.

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 Intensity Modulated Proton Therapy (IMPT) is generally safe for treating gynecologic cancers. Studies indicate that serious side effects, particularly those affecting the stomach and urinary systems, rarely occur with proton therapy, especially during initial treatments rather than repeat treatments in the same area.

One study found that IMPT might cause fewer stomach-related side effects compared to other radiation methods, suggesting it could be gentler on the body, particularly for uterine cancer patients. Overall, patients receiving IMPT for gynecologic cancers have tolerated it well, with most not experiencing serious problems.

While more research is needed, current findings are promising for those considering this treatment option.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Intensity Modulated Proton Therapy (IMPT) for gynecologic cancers because it offers a unique approach compared to standard photon radiation therapies like Volume Modulated Arc Therapy (VMAT). IMPT allows for more precise targeting of cancerous tissues, minimizing damage to surrounding healthy tissues due to its ability to deposit energy directly at the tumor site. This precision reduces side effects and potentially improves outcomes for patients. Unlike traditional photon therapy, which passes through the body, proton therapy stops at the tumor, offering a safer and more effective treatment option.

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

This trial will compare Photon Radiation Therapy with Proton Radiation Therapy for treating gynecologic cancers. Studies have shown that Intensity Modulated Proton Therapy (IMPT), which participants in this trial may receive, can effectively treat gynecologic cancers, such as endometrial and cervical cancer. Research indicates that this type of proton therapy may cause fewer side effects than traditional radiation methods. Specifically, one study found that patients experienced less severe stomach and urinary side effects with proton therapy. Another study highlighted that proton therapy could be more precise, protecting healthy tissue while targeting cancer cells. These findings suggest that proton therapy is a promising option for reducing side effects while effectively treating gynecologic cancers.12678

Who Is on the Research Team?

EN

Elizabeth Nichols, MD

Principal Investigator

University of Maryland Medical Center/Maryland Proton Treatment Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with newly diagnosed endometrial or cervical cancer who are planning to receive chemotherapy and radiation. Participants must be able to give consent, have a confirmed diagnosis, be in reasonably good health, and have insurance approval for proton therapy.

Inclusion Criteria

I am able and willing to sign a consent form for the study.
I have newly diagnosed endometrial or cervical cancer and am planning to receive chemo and radiation.
2. Histologic confirmation of malignancy (primary only)
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive either Photon Radiation Therapy (VMAT) or Proton Radiation Therapy (IMPT) for pelvic nodal irradiation

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of acute gastrointestinal toxicity and lymphocyte values

2 years
Regular visits over 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Intensity Modulated Proton Therapy (IMPT)

Trial Overview

The study compares two types of radiation treatments—photon (VMAT) versus proton (IMPT)—for people with gynecologic cancers. Patients are randomly assigned to one group or the other to see which treatment causes fewer side effects.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Photon RadiationActive Control1 Intervention
Group II: Proton RadiationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials
729
Recruited
540,000+

Citations

Clinical Outcomes of Intensity Modulated Proton Therapy ...

Twenty-five patients were treated for recurrent gynecologic cancers, whereas the remaining 4 patients had de novo gynecologic cancer with previous pelvic RT for ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37213483/

Clinical Outcomes of Intensity Modulated Proton Therapy ...

... therapy (IMPT) for gynecologic cancers. Methods and materials: We performed a retrospective analysis of all patients with gynecologic cancer ...

Proton Therapy Shows Promise in Reducing Toxicity and ...

While cervical cancer has seen a decrease in incidence due to HPV vaccination and improved screening, the cancers that are now diagnosed tend to ...

Clinical Outcomes of Intensity Modulated Proton Therapy ...

Complete remission of endometrial cancer stage IVC treated with multimodality treatment including immunotherapy and maintenance PARP inhibitor - A case report.

Dosimetric Advantage of Scanning Beam Proton Therapy in ...

Simple Summary: Pelvic radiation therapy is commonly used after surgery for gynecologic cancers such as endometrial and cervical cancer.

Outcomes of Proton Beam Therapy Compared With ...

Adjuvant PT is a promising treatment for patients with uterine cancer and may reduce patient-reported GI toxicity as compared with IMRT.

Treatment Tolerability and Toxicity of Postoperative Proton ...

Surgery is generally used for endometrial carcinoma and early-stage uterine cervical cancer patients. Depending on risk factors, postoperative (chemo)radiation ...

The role of proton therapy in gynecological radiation ...

1 Radi- ation therapy plays a prominent role in the treatment of cancers of the uterine corpus, cervix, vulva, and vagina, with limited role in ovarian cancer ...