Short-Course Radiation for Endometrial Cancer

(DeCRESCEndo Trial)

No longer recruiting at 1 trial location

Overseen By Jessika Contreras, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Investigational agents

Disqualifiers: Prior pelvic radiation, Uncontrolled illness, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a shorter course of radiation therapy for women who have undergone surgery for certain types of advanced endometrial cancer. Researchers aim to determine if this shorter treatment is as effective and less toxic than the usual 5-6 weeks of radiation. The treatment uses a focused type of radiation called intensity-modulated radiation therapy (IMRT) to target the pelvis. Women who have had a hysterectomy for stage III-IVA endometrial cancer or specific aggressive cancer types might be suitable candidates.

As an unphased trial, this study provides an opportunity 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 if you need to stop taking your current medications. However, if you are on investigational agents, you cannot participate in the trial.

What prior data suggests that this radiation therapy is safe for endometrial cancer patients?

Research has shown that intensity modulated radiation therapy (IMRT) is generally safe for treating endometrial cancer. Studies have found that patients receiving IMRT experience fewer side effects than those undergoing traditional radiation treatments. For instance, fewer patients report immediate stomach and bowel issues, such as nausea or diarrhea, with IMRT. Specifically, only 11% of patients had these side effects, compared to 19.2% with older methods. IMRT provides similar cancer treatment results but with less discomfort, suggesting it is well-tolerated and may be a safer option for managing endometrial cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment because it's a shorter, more focused approach to radiation therapy for endometrial cancer. Unlike traditional radiation therapies, which can require several weeks of daily sessions, intensity modulated radiation therapy (IMRT) in this study delivers just five high-dose treatments over a short period. Additionally, IMRT can target the cancer more precisely, reducing damage to surrounding healthy tissues. This method also allows for a simultaneous boost to any suspicious lymph nodes, potentially enhancing the treatment's effectiveness.

What evidence suggests that this radiation therapy is effective for endometrial cancer?

Research has shown that intensity modulated radiation therapy (IMRT), which participants in this trial will receive, holds promise for treating endometrial cancer. Studies have found that IMRT can focus radiation more precisely on cancerous areas, reducing radiation exposure to nearby healthy tissues. This precision can lower the risk of side effects, such as damage to the stomach and intestines. IMRT has been successfully used for similar cancers, helping to reduce short-term side effects. While researchers continue to gather information on its long-term safety and effectiveness, early results are encouraging. ^{1 5 6 7 8}

Who Is on the Research Team?

Jessika Contreras, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for women at least 18 years old who've had a radical hysterectomy within the last year for stage IIIA-IVA endometrial cancer or any stage with uterine serous, clear cell, or carcinosarcoma histology. Participants must have certain blood cell counts and be able to consent. Those with HIV can join if they meet specific health criteria.

Inclusion Criteria

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

Leukocytes ≥ 1,000 cumm

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

Exclusion Criteria

You are currently taking experimental drugs.

I do not have any ongoing serious illnesses like heart failure or severe infections.

I have had radiation treatment to my pelvic area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive five 5-Gy fractions of IMRT to the pelvis with elective simultaneous boost to any suspicious lymph node or residual disease to 30 Gy. Brachytherapy boost may be given within 2 weeks of radiation therapy completion.

3-4 weeks

Chemotherapy

Participants may receive chemotherapy following radiation, as per standard treatment protocols for endometrial cancer.

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Intensity modulated radiation therapy

Trial Overview The study tests short course radiation therapy after surgery in patients with advanced endometrial cancer. The aim is to see if this quicker treatment has less severe side effects while still controlling the cancer effectively compared to traditional longer treatments.

How Is the Trial Designed?

Group I: IMRT Experimental Treatment 1 Intervention

-Five 5-Gy fractions of IMRT will be given to the pelvis with elective simultaneous boost to any suspicious lymph node or residual disease to 30 Gy. -\*Brachytherapy boost (at the discretion of the PI) within 2 weeks of radiation therapy completion. Once or twice weekly for three weeks

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

In a study of 658 patients with high-risk endometrial cancer, intensity-modulated radiation therapy (IMRT) was associated with significantly fewer grade ≥2 adverse events, such as diarrhea and hematologic issues, compared to 3-dimensional conformal radiation therapy (3DCRT) during follow-up.

IMRT also showed a trend towards fewer patient-reported symptoms like bowel urgency and abdominal cramps during treatment, indicating it may provide a better quality of life for patients undergoing radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Therapy Techniques and Treatment-Related Toxicity in the PORTEC-3 Trial: Comparison of 3-Dimensional Conformal Radiation Therapy Versus Intensity-Modulated Radiation Therapy. Wortman, BG., Post, CCB., Powell, ME., et al.[2022]

In a study of 67 patients with endometrial cancer, those receiving proton beam therapy (PT) reported significantly less diarrhea during and after treatment compared to those receiving intensity-modulated radiation therapy (IMRT), suggesting PT may be a safer option for gastrointestinal side effects.

Patients treated with IMRT experienced higher rates of grade 3+ gastrointestinal toxicity, including loss of bowel control, indicating that PT could potentially lead to better patient-reported outcomes in terms of gastrointestinal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Proton Beam Therapy Compared With Intensity-Modulated Radiation Therapy for Uterine Cancer. Anderson, JD., Voss, MM., Laughlin, BS., et al.[2023]

Intensity-modulated radiation therapy (IMRT) is an advanced technique that allows for more precise targeting of tumors in gynecologic cancers, minimizing damage to surrounding healthy tissues.

This review highlights the effectiveness of IMRT as both a primary treatment and a follow-up to surgery, showcasing its potential to improve patient outcomes while reducing adverse side effects associated with traditional radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy in gynecologic malignancies: current status and future directions. Kochanski, JD., Mell, LK., Roeske, JC., et al.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3903584/

Uptake and Outcomes of Intensity-Modulated Radiation ... In conclusion, our findings suggest that the use of IMRT has increased over time for women with uterine cancer undergoing pelvic radiotherapy. Despite the ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825813001546

Uptake and outcomes of intensity-modulated radiation ... Early studies have shown that IMRT reduces the radiation dose delivered to normal pelvic structures and suggest that IMRT is associated with lower rates of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9258613/

INTENSITY-MODULATED RADIOTHERAPY FOR ... IMRT can serve as salvage therapy of para-aortic recurrence of endometrial cancer. However, the risk of severe gastrointestinal toxic effects is high.

4. practicalradonc.org practicalradonc.org/article/S1879-8500(22)00273-9/fulltext

Radiation Therapy for Endometrial Cancer: An American ... Outcome and safety analysis of endometrial cancer ... Clinical outcomes of intensity-modulated pelvic radiation therapy for carcinoma of the ...

5. redjournal.org redjournal.org/article/S0360-3016(15)01932-X/fulltext

Long-term Outcomes Using Adjuvant Pelvic Intensity ... Intensity modulated RT (IMRT) has been shown to reduce acute toxicities, but limited data exist to confirm safety and efficacy with extended follow-up.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33999750/

Outcome and safety analysis of endometrial cancer ... Acute grade ≥2 GI toxicity was significantly less in patients treated with IMRT compared to those treated with 3DCRT (11.0% vs. 19.2%, p=.004).

7. sciencedirect.com sciencedirect.com/science/article/pii/S2331518023002354

Outcomes of Proton Beam Therapy Compared With ... Our data show PT may decrease the frequency of diarrhea at the end of radiation therapy and lower the risk of bowel incontinence at 12 months as compared with ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/0284186X.2021.1926537

Outcome and safety analysis of endometrial cancer ... We found that IMRT-treated EC patients showed comparable clinical outcomes but with a lower incidence of GI toxicities compared with those treated with 3DCRT.