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Radiation Therapy

Short-Course Radiation for Endometrial Cancer (DeCRESCEndo Trial)

Phase 1

Waitlist Available

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

No Placebo-Only Group

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.

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.

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 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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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%

Hearing impaired

49%

Late RT toxicity: Other: NOS

49%

Neutropenia

47%

Late RT toxicity: Auditory/hearing: NOS

46%

Vomiting NOS

41%

Esophagitis NOS

41%

Late RT toxicity: Esophagus: NOS

40%

Late RT toxicity: Subcutaneous tissue (within RT field): NOS

38%

Hyponatremia

35%

Pain-other

35%

Dysphagia

35%

Pain due to radiation

34%

Peripheral sensory neuropathy

32%

Late RT toxicity: Skin (within RT field): NOS

29%

Alopecia

28%

Dehydration

28%

Blood albumin decreased

28%

Taste disturbance

26%

Platelet count decreased

26%

Anorexia

25%

Hypocalcemia

25%

Hearing-Other

24%

Hyperglycemia NOS

24%

Lymphopenia

22%

Hypokalemia

22%

Stomatitis

22%

Blood magnesium decreased

22%

Epistaxis

21%

Constipation

19%

Late RT toxicity: Joint: NOS

19%

Edema NOS

19%

Renal/GU-Other

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%

Hyperkalemia

10%

Metabolic-Other

10%

Otitis media serous NOS

10%

Infection NOS

Hypophosphatemia

Esophageal spasm

Hypotension NOS

Blood bilirubin increased

Peripheral motor neuropathy

Dyspnea NOS

Dermatitis exfoliative NOS

Erythema multiforme

Rigors

Gamma-glutamyltransferase increased

Dysphonia

Hiccups

Rhinitis allergic NOS

Late RT toxicity: Bone (incl. osteonecrosis): NOS

Packed red blood cell transfusion

Infection with grade 3 or 4 neutropenia

Earache

Dizziness (exc vertigo)

Neuralgia NOS

Confusion

Insomnia NEC

Pulmonary-other

Toxicoderma

Joint, muscle, or bone-Other

Febrile neutropenia

Syncope

Hypoxia

Pneumonitis NOS

Otitis externa (exc boil of meatus) NOS

Endocrine-Other

Infection, Other

Hallucination NOS

Sinus tachycardia

Supraventricular arrhythmia NOS

Ventricular arrhythmia NOS

Implant infection

Infection with unknown ANC

CD4 lymphocytes decreased

Inappropriate ADH secretion

Leukocytes for BMT

Weight increased

Acidosis NOS

Tumour pain

Neurologic-Other

Hemorrhage NOS

Thrombosis NOS

Left ventricular failure

Anxiety NEC

Depression NEC

Renal failure NOS

100%

80%

60%

40%

20%

Study treatment Arm

IMRT +/- Chemotherapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met