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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation
Awards & highlights
DeCRESCEndo Trial 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.
DeCRESCEndo Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am 18 years old or older.
Select...
My cancer is confirmed to be a specific type of advanced endometrial cancer.
DeCRESCEndo Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation
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 moreSide effects data
From 2016 Phase 2 trial • 68 Patients • NCT0005778590%
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%
Pyrexia
15%
Hypothyroidism
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%
Insomnia NEC
6%
Late RT toxicity: Bone (incl. osteonecrosis): NOS
6%
Confusion
6%
Packed red blood cell transfusion
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%
Febrile neutropenia
4%
Pneumonitis NOS
4%
Hypoxia
4%
Syncope
3%
Infection, Other
3%
Endocrine-Other
3%
Otitis externa (exc boil of meatus) NOS
3%
Hallucination NOS
1%
Neurologic-Other
1%
Infection with unknown ANC
1%
Ventricular arrhythmia NOS
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
DeCRESCEndo 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
1,935 Previous Clinical Trials
2,299,782 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.You are currently taking experimental drugs.I do not have any ongoing serious illnesses like heart failure or severe infections.I am 18 years old or older.I can understand and am willing to sign a consent form.I have had radiation treatment to my pelvic area.My cancer is confirmed to be a specific type of advanced endometrial cancer.I have HIV but my CD4+ T-cell count is above 350 and I haven't had any major infections in the last year.I had a radical hysterectomy within the last year.
Research Study Groups:
This trial has the following groups:- Group 1: IMRT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the prime goals of this clinical experiment?
"The focal metric of this medical trial, occurring over a four week period from commencement to cessation of radiation therapy, is the incidence of late-term hematologic, gastrointestinal and genitourinary adverse events. Secondary outcomes include locoregional control (through histological or radiographic evidence), quality of life as measured by FACT-En questionnaire scores ranging from 0 - 4 with higher values indicating better health state and overall disease free survival."
Answered by AI
What is the uppermost limit for participants in this experiment?
"Indeed, the clinicaltrials.gov database indicates that this trial is still actively recruiting patients. The study was initially advertised on July 7th 2020 and has since been amended for the last time on July 27th 2022. 25 participants are needed at one medical centre."
Answered by AI
Is there availability to join this research endeavor?
"Indeed, the information accessible on clinicaltrials.gov suggests that this research is actively enrolling individuals. It was first listed on July 7th 2020 and has been recently updated in late July of 2022. 25 participants are sought after across one site location."
Answered by AI
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