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Radiation Therapy

Hypofractionated Radiation Therapy for Merkel Cell Carcinoma

Phase 2
Recruiting
Led By Devarati Mitra
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status ≤3
Patients must have no evidence of distant metastasis as determined by clinical examination and any form of imaging
Must not have
Patients with distant metastases
Previous radiation therapy to the site of planned primary or nodal radiation treatment such that the prior site of treatment would be encompassed by the radiation field needed to treat the current cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if it is just as effective to give a higher dose of radiation in 10 treatments as it is to give a lower dose of radiation in 25 treatments for Merkel cell carcinoma patients receiving immunotherapy.

Who is the study for?
This trial is for adults over 18 with Merkel Cell Carcinoma (MCC) who've had surgery to remove the tumor or affected lymph nodes within the last 4 months and show no signs of cancer spread. They must be able to consent, use contraception, and have a performance status allowing daily activities with some limitations.
What is being tested?
The study tests if a shorter course of radiation therapy (3.6 Gy x 10 fractions) is as safe and effective as the standard longer course in treating MCC patients, who may also be receiving immunotherapy treatments at any stage.
What are the potential side effects?
Radiation therapy can cause skin irritation, fatigue, mild swelling around treated areas, changes in skin color or texture, hair loss at treatment site, nausea and potential late effects like fibrosis or secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am capable of limited self-care.
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My cancer has not spread to distant parts of my body as confirmed by tests.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to distant parts of my body.
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I've had radiation before in the same area where my current cancer needs treatment.
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2013 Phase 3 trial • 397 Patients • NCT00004054
78%
Menopausal symptoms
60%
Urinary frequency
52%
Impotence
47%
Late RT Toxicity: Bladder: NOS
39%
Diarrhea NOS
27%
Late RT Toxicity: Bowel: NOS
26%
Fatigue
26%
Late RT Toxicity: Other GU: NOS
21%
Proctitis NOS
21%
Dysuria
14%
Libido decreased
14%
Dermatitis radiation NOS
12%
Late RT Toxicity: Other: NOS
12%
Late RT Toxicity: Other GI: NOS
12%
Hemoglobin decreased
12%
Alanine aminotransferase increased
9%
Gynaecomastia
8%
Urinary retention
7%
Pain-other
7%
Aspartate aminotransferase increased
6%
Rectal bleeding
6%
Constipation
6%
Leukopenia NOS
4%
Edema NOS
4%
Hematuria present
4%
Renal/GU-Other
3%
Arthralgia
3%
Blood creatinine increased
3%
Dyspnea NOS
3%
Dermatitis exfoliative NOS
2%
Depression NEC
2%
Nausea
2%
Hyperglycemia NOS
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Platelet count decreased
1%
Hyponatremia
1%
Hypocalcemia
1%
Blood albumin decreased
1%
Stomatitis
1%
Weight decreased
1%
Anorexia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus 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: Radiation therapyExperimental Treatment1 Intervention
Patients receive radiation therapy in 10 daily fractions (M-F) over 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation therapy
2013
Completed Phase 3
~2850

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,557 Total Patients Enrolled
Devarati MitraPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
168 Total Patients Enrolled

Media Library

Hypofractionated Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05100095 — Phase 2
Neuroendocrine Carcinoma Research Study Groups: Radiation therapy
Neuroendocrine Carcinoma Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT05100095 — Phase 2
Hypofractionated Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05100095 — Phase 2
~29 spots leftby Sep 2028
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