30 Participants NeededMy employer runs this trial

MR-Guided Radiation Therapy for Endometrial Cancer

(ADAPT-EC Trial)

LH
Overseen ByLara Hathout, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of radiation therapy for people with endometrial cancer. The treatment, called MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT), uses an MRI machine to guide and adjust radiation. This approach could enhance safety and effectiveness by protecting nearby healthy organs. It targets individuals diagnosed with endometrial cancer who require additional pelvic radiation therapy after surgery. Participants must not have had previous pelvic radiation and must be able to complete specific health questionnaires. As an unphased trial, this study allows patients to contribute to innovative research that could improve future cancer treatments.

What prior data suggests that MR-guided adaptive pelvic IMRT is safe for endometrial cancer patients?

Research has shown that MR-guided adaptive pelvic IMRT, a type of radiation therapy, is generally safe and well-tolerated. One study found that patients who received this treatment experienced manageable side effects and reported positive experiences, with any long-term side effects deemed acceptable.

Another study demonstrated that this radiation therapy accurately targets cancer cells while protecting nearby healthy organs, reducing the risk of harm. This precision minimizes unwanted side effects, which is crucial for patient comfort and safety.

Overall, the treatment has shown promise in terms of safety, with most patients experiencing only mild to moderate side effects. This makes it a viable option for those considering joining a clinical trial for endometrial cancer.12345

Why are researchers excited about this trial?

Unlike the traditional radiation therapy for endometrial cancer, which typically involves a fixed radiation dose plan, MR-guided adaptive pelvic IMRT offers a personalized approach. This method uses MRI guidance to tailor the radiation dose to the patient's anatomy on a daily basis, allowing for precise targeting of the cancer while sparing surrounding healthy tissues. Researchers are excited about this treatment because it promises enhanced precision and potentially fewer side effects, which could lead to better outcomes for patients. Additionally, incorporating vaginal brachytherapy as needed provides a versatile treatment strategy that can be adjusted according to individual patient needs.

What evidence suggests that MR-guided adaptive pelvic IMRT is effective for endometrial cancer?

Research has shown that MRI-guided radiation therapy for treating endometrial cancer appears promising. This trial will evaluate MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT) as an experimental treatment. This method focuses the radiation more precisely on the cancer, reducing the impact on nearby healthy organs. Some studies have improved the accuracy of targeting the cancer in 82–100% of treatments. Specifically, one study found that using this type of radiation therapy after surgery is safe and effective for patients with endometrial cancer. Additionally, MRI-guided therapy has resulted in the complete disappearance of tumors in some patients. Overall, these findings suggest that this treatment could effectively manage endometrial cancer.14567

Who Is on the Research Team?

LM

Lara M Hathout

Principal Investigator

Rutgers University - Cancer Institute

Are You a Good Fit for This Trial?

This trial is for people with endometrial cancer who need additional pelvic radiation after their main treatment. Participants should be healthy enough for radiation and able to undergo MRI scans.

Inclusion Criteria

My cancer has markers linked to a worse outlook.
I am 18 years old or older.
Ability to provide informed consent
See 9 more

Exclusion Criteria

I have received radiation therapy to my pelvic area.
I cannot safely receive pelvic radiation due to another health condition.
Presence of a hip prosthesis that would compromise treatment planning or delivery

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MR-guided adaptive pelvic IMRT over approximately 3 weeks, involving 15 treatment sessions with daily onboard MRI and online adaptive replanning

3 weeks
15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments for acute toxicity and quality of life

Up to 2 years
Regular visits every 6-12 months

What Are the Treatments Tested in This Trial?

Interventions

  • MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT)

Trial Overview

The study is testing a new type of daily pelvic radiation therapy called MR-guided adaptive IMRT, given over 15 sessions. The goal is to see if this approach is safe and effective.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Experimental: MR-guided Adaptive Pelvic IMRTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

Citations

Adaptive Daily MR-Guided Adjuvant Pelvic Therapy ...

The purpose of this research study is to evaluate a new way of delivering radiation therapy for patients with endometrial cancer. This study ...

Daily Online Adaptive Radiation Therapy of Postoperative ...

Pelvic radiation therapy plays a crucial role in postoperative endometrial and cervical cancer and has been demonstrated to reduce the local recurrence rate and ...

Adaptive Daily MR-Guided Adjuvant Pelvic Therapy ...

The purpose of this research study is to evaluate a new way of delivering radiation therapy for patients with endometrial cancer.

Online Adaptive Magnetic Resonance-guided Radiation ...

The estimated 1-year overall survival was 88.9%. The median treatment time was 47 days (range 10–87 days). During external beam radiation therapy, 10 (83.3%) ...

Radiotherapy for gynecological cancer

Daily MR-guided adaptation in cervical cancer improves target coverage and reduces bladder/rectum doses, highlighting the benefit of online adaptive ...

Long-term patient experience with online MR-guided ... - PMC

This study aimed to evaluate patient-reported outcome measures (PROMs) and long-term toxicity profiles associated with MR-guided radiotherapy, with a particular ...

Daily Online Adaptive Radiation Therapy of Postoperative ...

Pelvic radiation therapy plays a crucial role in postoperative endometrial and cervical cancer and has been demonstrated to reduce the local recurrence rate ...