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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

Studying adjuvant hypofractionated whole pelvis radiation therapy in Endometrial Cancer.

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 data supports the effectiveness of the treatment Hypofractionated Whole Pelvis Radiation Therapy for Endometrial Cancer?

Research on hypofractionated radiation therapy in prostate cancer suggests that it can be effective and well-tolerated, with potential benefits in shortening treatment time and maintaining low side effects. Although specific data for endometrial cancer is limited, similar techniques in prostate cancer show promise for improving outcomes with manageable side effects. ^{1 2 3 4 5}

Is hypofractionated whole pelvis radiation therapy safe for humans?

Research on hypofractionated whole pelvis radiation therapy, particularly in prostate cancer, suggests that it generally has low levels of side effects when compared to traditional radiation therapy. However, it is still considered investigational, and more studies are needed to fully understand its safety profile. ^{1 3 4 5 6}

How is hypofractionated radiation therapy different for endometrial cancer treatment?

Hypofractionated radiation therapy for endometrial cancer involves delivering higher doses of radiation in fewer sessions compared to traditional radiation therapy, potentially reducing the overall treatment time while maintaining effectiveness. This approach is being explored for its ability to spare healthy tissues and reduce side effects, similar to its use in other cancers like prostate and breast cancer. ^{1 2 3 7 8}

Research Team

Teresa Meier, MD

Principal Investigator

University of Cincinnati

Eligibility Criteria

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 am 18 years old or older.

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

References

1. England 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. [2010]

2. Switzerland 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Whole-pelvic nodal radiation therapy in the context of hypofractionation for high-risk prostate cancer patients: a step forward. [2022]

4. England 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. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. Germany pubmed.ncbi.nlm.nih.gov

Assessing the toxicity after moderately hypofractionated prostate and whole pelvis radiotherapy compared to conventional fractionation. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for the palliation of advanced pelvic malignancy. [2019]

8. Japan pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy for breast cancer patients treated by breast-conserving surgery: short-term morbidity and preliminary results. [2018]