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Radiation Therapy

Short-Course Radiation for Endometrial Cancer (DeCRESCEndo Trial)

Phase 1
Recruiting
Led By Stephanie Markovina, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status ≤ 2
At least 18 years of age.
Must not have
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, inflammatory bowel disease, or irritable bowel disease.
Prior radiation to the pelvis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation
Awards & highlights

Summary

This trial is testing whether a shorter course of radiation is just as effective as the standard radiation treatment for endometrial cancer patients.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include acute and late reactions that could affect various organs but are expected to occur in less than 10% of patients. Specific side effects aren't listed but would typically relate to radiation exposure such as skin irritation, fatigue, and gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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My cancer is confirmed to be a specific type of advanced endometrial cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any ongoing serious illnesses like heart failure or severe infections.
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I have had radiation treatment to my pelvic area.
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I have HIV but my CD4+ T-cell count is above 350 and I haven't had any major infections in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events
Incidence of late hematologic, gastrointestinal, and genitourinary adverse events
Secondary outcome measures
Change in patient-reported urinary and gastrointestinal toxicity as measured by PRO-CTCAE
Change in patient-reported urinary and gastrointestinal toxicity as measured by bowel/bladder domains of EPIC-26
Change in quality of life as measured by FACT-En
+4 more

Side effects data

From 2016 Phase 2 trial • 68 Patients • NCT00057785
90%
Dry mouth
87%
Salivary gland disorder NOS
75%
Hemoglobin decreased
75%
Late RT toxicity: Salivary gland: NOS
74%
Radiation mucositis
74%
Fatigue
74%
Leukopenia NOS
68%
Nausea
63%
Dermatitis radiation NOS
60%
Late RT toxicity: Mucous membrane: NOS
59%
Weight decreased
49%
Late RT toxicity: Other: NOS
49%
Hearing impaired
49%
Neutropenia
47%
Late RT toxicity: Auditory/hearing: NOS
46%
Vomiting NOS
41%
Late RT toxicity: Esophagus: NOS
41%
Esophagitis NOS
40%
Late RT toxicity: Subcutaneous tissue (within RT field): NOS
38%
Hyponatremia
35%
Pain due to radiation
35%
Dysphagia
35%
Pain-other
34%
Peripheral sensory neuropathy
32%
Late RT toxicity: Skin (within RT field): NOS
29%
Alopecia
28%
Taste disturbance
28%
Blood albumin decreased
28%
Dehydration
26%
Anorexia
26%
Platelet count decreased
25%
Hearing-Other
25%
Hypocalcemia
24%
Lymphopenia
24%
Hyperglycemia NOS
22%
Stomatitis
22%
Blood magnesium decreased
22%
Epistaxis
22%
Hypokalemia
21%
Constipation
19%
Edema NOS
19%
Renal/GU-Other
19%
Late RT toxicity: Joint: NOS
19%
Late RT toxicity: Larynx: NOS
19%
Alanine aminotransferase increased
18%
Blood creatinine increased
16%
Cough
15%
Hypothyroidism
15%
Pyrexia
15%
Headache NOS
13%
Diarrhea NOS
13%
Skin discoloration
13%
Aspartate aminotransferase increased
13%
Blood alkaline phosphatase NOS increased
12%
Hematologic-Other
12%
GI-other
12%
Skin-Other
10%
Infection NOS
10%
Metabolic-Other
10%
Otitis media serous NOS
10%
Hyperkalemia
9%
Blood bilirubin increased
9%
Peripheral motor neuropathy
9%
Esophageal spasm
9%
Hypotension NOS
9%
Hypophosphatemia
9%
Dyspnea NOS
9%
Dermatitis exfoliative NOS
9%
Erythema multiforme
7%
Gamma-glutamyltransferase increased
7%
Dysphonia
7%
Hiccups
7%
Rhinitis allergic NOS
7%
Rigors
6%
Confusion
6%
Packed red blood cell transfusion
6%
Insomnia NEC
6%
Late RT toxicity: Bone (incl. osteonecrosis): NOS
6%
Infection with grade 3 or 4 neutropenia
6%
Earache
6%
Dizziness (exc vertigo)
6%
Neuralgia NOS
6%
Pulmonary-other
6%
Toxicoderma
6%
Joint, muscle, or bone-Other
4%
Hypoxia
4%
Febrile neutropenia
4%
Pneumonitis NOS
4%
Syncope
3%
Infection, Other
3%
Endocrine-Other
3%
Otitis externa (exc boil of meatus) NOS
3%
Hallucination NOS
1%
Ventricular arrhythmia NOS
1%
Infection with unknown ANC
1%
Neurologic-Other
1%
Tumour pain
1%
Sinus tachycardia
1%
Supraventricular arrhythmia NOS
1%
Implant infection
1%
CD4 lymphocytes decreased
1%
Leukocytes for BMT
1%
Weight increased
1%
Acidosis NOS
1%
Hemorrhage NOS
1%
Thrombosis NOS
1%
Inappropriate ADH secretion
1%
Left ventricular failure
1%
Anxiety NEC
1%
Depression NEC
1%
Renal failure NOS
100%
80%
60%
40%
20%
0%
Study treatment Arm
IMRT +/- Chemotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: IMRTExperimental Treatment1 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity modulated radiation therapy
2003
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,949 Previous Clinical Trials
2,307,533 Total Patients Enrolled
6 Trials studying Endometrial Cancer
455 Patients Enrolled for Endometrial Cancer
Stephanie Markovina, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
Jessika Contreras, M.D.Principal InvestigatorWashington University School of Medicine

Media Library

Intensity modulated radiation therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04386993 — Phase 1
Endometrial Cancer Research Study Groups: IMRT
Endometrial Cancer Clinical Trial 2023: Intensity modulated radiation therapy Highlights & Side Effects. Trial Name: NCT04386993 — Phase 1
Intensity modulated radiation therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04386993 — Phase 1
~5 spots leftby Aug 2025
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