Hypofractionated Radiation Therapy for Endometrial Cancer

Overseen By Teresa Meier, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Teresa Meier

Must not be taking: Investigational agents

Disqualifiers: Inflammatory bowel disease, Periaortic disease, others

Stay on Your Current Meds You can continue your current medications while participating

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of delivering radiation therapy for individuals with endometrial cancer. It focuses on hypofractionated therapy, which involves fewer but larger doses of radiation over a shorter period. The researchers aim to determine if this method matches the effectiveness of traditional approaches while potentially reducing side effects. Suitable candidates for this trial include those diagnosed with stage I, II, or III endometrial cancer who have already undergone surgery to remove their uterus and ovaries. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future cancer treatments.

Do I need to stop my current medications for the trial?

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

What prior data suggests that hypofractionated whole pelvis radiation therapy is safe for endometrial cancer?

Research has shown that hypofractionated whole-pelvis radiation therapy (WPRT) is generally safe for women with endometrial cancer. Studies have examined patient tolerance, and results indicate it is well-tolerated with manageable side effects.

One study found that its side effects were similar to those of traditional radiation treatments. Another study supported these findings, showing that the shorter treatment schedule did not increase risks.

Although this radiation therapy remains under study, the results so far are encouraging. It appears to have a good safety profile, indicating it is unlikely to cause serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hypofractionated radiation therapy for endometrial cancer because it offers a faster and potentially more convenient treatment option compared to the standard radiation therapy. Traditional radiation therapy typically involves lower doses over several weeks, but this new approach uses higher doses over a shorter period, either 15 or 10 sessions. This not only reduces the treatment timeframe, making it more manageable for patients, but it may also lead to similar or even improved effectiveness and safety. By shortening treatment duration, patients might experience less disruption to their daily lives, which is a significant advantage over conventional methods.

What evidence suggests that hypofractionated WPRT might be an effective treatment for endometrial cancer?

Research has shown that hypofractionated whole pelvis radiation therapy (WPRT) can effectively treat endometrial cancer. In this trial, participants will receive hypofractionated WPRT, which delivers higher doses of radiation in fewer sessions, a method known as hypofractionation. Studies have found that this therapy helps control cancer in the pelvic area, which is crucial for women with higher-risk endometrial cancer. Early results suggest it is safe and might work as well as traditional radiation schedules. By reducing the number of treatment sessions, this approach could make the therapy more convenient without losing effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Teresa Meier, MD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stage I, II, or III endometrial cancer who've had a hysterectomy and possibly lymph node removal. It's suitable for those needing pelvic radiation but not vaginal cuff brachytherapy due to anatomy or higher risk of nodal recurrence. Participants must be in good general health (ECOG ≤2) and able to consent.

Inclusion Criteria

I have stage I, II, or III endometrial cancer and need pelvic radiation as advised by my oncologist.

Ability to understand and the willingness to sign a written informed consent document.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I have been diagnosed with Inflammatory Bowel Disease.

I have active disease in the nodes around my aorta confirmed by surgery.

I have had pelvic radiotherapy before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive hypofractionated whole pelvis radiation therapy to determine the maximum tolerated dose per fraction

3 months

15 sessions for Cohort 1, 10 sessions for Cohort 2

Follow-up

Participants are monitored for safety and effectiveness after radiation therapy, focusing on acute gastrointestinal and genitourinary toxicity

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated WPRT

Trial Overview The study tests hypofractionated whole pelvis radiation therapy as an additional treatment after surgery for endometrial cancer patients. The goal is to see if this type of targeted radiation can effectively treat the area around where the tumor was located.

How Is the Trial Designed?

Group I: Hypofractionated Whole-Pelvis Radiotherapy Experimental Treatment 1 Intervention

Hypofractionated WPRT Cohort 1: 41.25 Gy in 15 fx Cohort 2: 38 Gy in 10 fx

Who Is Running the Clinical Trial?

Teresa Meier

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

The half-beam technique (VMAT-HF) for whole pelvic radiation therapy (WPRT) significantly reduces the irradiated volumes of the small intestine and colon by up to 35% and 15%, respectively, compared to conventional full-field techniques (VMAT-FF), leading to lower normal tissue complication probabilities (NTCP).

VMAT-HF achieves superior dose conformity while using 60%-70% less intensity modulation complexity than VMAT-FF, without sacrificing beam delivery efficiency, making it a promising approach to minimize gastrointestinal toxicities in patients undergoing WPRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Organs-at-Risk Dose Sparing in Volumetric Modulated Arc Therapy Using a Half-Beam Technique in Whole Pelvic Irradiation. Jang, H., Park, J., Artz, M., et al.[2022]

In a study of 41 patients with high-risk localized prostate cancer, combining whole-pelvis irradiation with a stereotactic body radiotherapy (SBRT) boost resulted in a high 4-year biochemical failure-free survival rate of 91.9%, indicating effective cancer control.

The treatment was associated with minimal toxicity, with no severe (grade 3) gastrointestinal or genitourinary side effects reported, suggesting that this approach is safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. Lin, YW., Lin, LC., Lin, KL.[2020]

In a study of 339 breast cancer patients receiving hypofractionated radiotherapy, the majority experienced mild to moderate acute skin toxicity, with only 4% reporting severe reactions, indicating a generally well-tolerated treatment.

Radiation pneumonitis occurred in 3.2% of patients, primarily those receiving regional lymphatics radiotherapy, suggesting that while hypofractionated schedules are effective, careful monitoring is needed for specific side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for breast cancer patients treated by breast-conserving surgery: short-term morbidity and preliminary results. Plataniotis, GA., Theofanopoulou, MA., Sotiriadou, K., et al.[2018]

In a study of 263 prostate cancer patients treated with either moderately hypofractionated (HF) or conventionally fractionated (CF) whole-pelvis radiotherapy, acute gastrointestinal (GI) toxicities were similar between the two groups, indicating that HF is a safe option.

Acute genitourinary (GU) toxicity was lower in the HF group compared to the CF group, suggesting that HF may have a more favorable safety profile for GU side effects, although further randomized trials are needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the toxicity after moderately hypofractionated prostate and whole pelvis radiotherapy compared to conventional fractionation. Moll, M., Goldner, G.[2023]

This phase II study involves 58 patients with high-risk prostate cancer, comparing the effects of hypofractionated whole pelvis radiotherapy (WPRT) to conventionally fractionated WPRT, focusing on late bowel toxicity as the primary endpoint.

If hypofractionated WPRT proves to be well-tolerated and effective, it could become the new standard of care for treating high-risk prostate cancer, offering a more convenient treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is hypofractionated whole pelvis radiotherapy (WPRT) as well tolerated as conventionally fractionated WPRT in prostate cancer patients? The HOPE trial. Mendez, LC., Arifin, AJ., Bauman, GS., et al.[2021]

In a study involving ten postoperative endometrial cancer patients, both Intensity-modulated radiotherapy (IMRT) and Helical tomotherapy (HT) demonstrated superior dose conformity and lower integral doses to organs at risk (OARs) compared to three-dimensional conformal radiotherapy (3D-CRT).

HT provided better dose homogeneity and reduced integral doses to the rectum and bladder compared to IMRT, although it slightly increased the integral dose to pelvic bones and normal tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric comparison of postoperative whole pelvic radiotherapy for endometrial cancer using three-dimensional conformal radiotherapy, intensity-modulated radiotherapy, and helical tomotherapy. Yang, R., Xu, S., Jiang, W., et al.[2010]

Prostate hypofractionation, which involves delivering higher doses of radiation in fewer sessions, shows low morbidity and may improve outcomes for high-risk prostate cancer patients, especially when using advanced techniques like high-dose-rate brachytherapy and image-guided intensity modulated radiation therapy.

Combining whole-pelvic radiation therapy with hypofractionated prostate radiation is feasible but still under investigation, suggesting that targeting pelvic lymph nodes at high risk for cancer involvement could enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-pelvic nodal radiation therapy in the context of hypofractionation for high-risk prostate cancer patients: a step forward. Kaidar-Person, O., Roach, M., Créhange, G.[2022]

A study involving 42 patients with advanced pelvic cancers showed that a hypofractionated radiotherapy regimen (30 Gy in three fractions) provided effective symptom relief with manageable side effects.

The treatment was particularly effective for patients with advanced rectal and ovarian tumors, indicating potential benefits for these specific cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for the palliation of advanced pelvic malignancy. Hodson, DI., Malaker, K., McLellan, W., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04683653

Study of Pelvic Hypofractionated Radiotherapy in ... This study will investigate if a shorter treatment course (known as "hypofractionation") for pelvic radiation is safe for women with endometrial cancer.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.TPS5631

RT-PACE: Phase I/II study of adjuvant whole pelvic ... Background: Whole pelvic radiation therapy (WPRT) improves locoregional control in women with high-intermediate and high-risk endometrial cancer ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04458402

NCT04458402 | Adjuvant Hypofractionated Whole Pelvis ... This is a Phase I study evaluating the safety of adjuvant hypofractionated whole pelvis radiation therapy (WPRT) in endometrial cancer.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10814353/

Hypofractionated Radiotherapy in Gynecologic ... University of Chicago Phase I Safety Study of Whole Pelvic Hypofractionated Radiotherapy in Women with Endometrial Cancer; NCT04683653.

5. ejgo.org ejgo.org/Synapse/Data/PDFData/1114JGO/jgo-37-e4.pdf

Postoperative conventional versus A recent study on ultra- hypofractionation, which administered 30 Gy in 5 fractions to patients with endometrial cancer using stereotactic body ...

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/264387

Study of Pelvic Hypofractionated Radiotherapy in ... This study will investigate if a shorter treatment course (known as hypofractionation) for pelvic radiation is safe for women with endometrial cancer.