Short-Course Radiation for Endometrial Cancer

(DeCRESCEndo Trial)

Overseen By Jessika Contreras, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to evaluate short course radiation in the post-operative female pelvis after hysterectomy in stage III-IVA endometrial adenocarcinoma patients, or any stage patients with uterine serous or carcinosarcoma histology. The investigators hypothesize that short course pelvic radiation will have an acute and late grade 3-4 toxicity rate \< 10%, and patients will benefit from both convenient and effective loco-regional control comparable to the traditional 5-6 weeks of radiation.

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 data supports the effectiveness of the treatment Intensity modulated radiation therapy for endometrial cancer?

Research shows that intensity-modulated radiation therapy (IMRT) can effectively control disease and improve survival rates in endometrial cancer by precisely targeting cancerous areas while sparing healthy tissue. This approach has been shown to reduce side effects compared to traditional radiation methods. ^{1 2 3 4 5}

Is short-course radiation therapy safe for endometrial cancer patients?

Research shows that intensity-modulated radiation therapy (IMRT) for endometrial cancer is generally safe, with studies indicating it may lead to fewer side effects compared to older radiation methods. It has been tested in various settings, showing fewer bowel-related side effects and better protection of normal tissues. ^{6 7 8 9 10}

How is the treatment Intensity modulated radiation therapy (IMRT) different for endometrial cancer?

Intensity modulated radiation therapy (IMRT) for endometrial cancer is unique because it allows for precise targeting of radiation to the cancerous area, potentially reducing damage to surrounding healthy tissues and minimizing side effects, especially in the bowel. This makes it a promising alternative to traditional radiation methods like high-dose-rate brachytherapy. ^{1 2 5 7 9}

Research Team

Jessika Contreras, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Radiation dose escalation using intensity modulated radiation therapy for gross unresected node-positive endometrial cancer. [2018]

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

Clinical outcome of adjuvant treatment of endometrial cancer using aperture-based intensity-modulated radiotherapy. [2008]

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

Intensity-modulated radiation therapy in gynecologic malignancies: current status and future directions. [2016]

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

Postoperative radiation therapy for surgically staged endometrial cancer: impact of time factors (overall treatment time and surgery-to-radiation interval) on outcome. [2022]

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

A dosimetric analysis of intensity-modulated radiation therapy (IMRT) as an alternative to adjuvant high-dose-rate (HDR) brachytherapy in early endometrial cancer patients. [2019]

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

Outcomes of Proton Beam Therapy Compared With Intensity-Modulated Radiation Therapy for Uterine Cancer. [2023]

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

Postoperative intensity-modulated radiotherapy in low-risk endometrial cancers: final results of a Phase I study. [2018]

8. United States 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. [2022]

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

A phase II study of intensity modulated radiation therapy to the pelvis for postoperative patients with endometrial carcinoma: radiation therapy oncology group trial 0418. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

Factors determining acute normal tissue reactions during postoperative radiotherapy in endometrial cancer: analysis of 317 consecutive cases. [2019]