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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
If planned for adjuvant nodal radiation therapy, a patient should have had prior positive sentinel lymph node biopsy with any degree of nodal involvement within 4 months of starting RT and no completion nodal dissection, or lymph node dissection within 4 months of starting RT and high risk nodal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I had a positive lymph node biopsy and am planning radiation therapy without full lymph node removal.
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I had surgery to remove my primary MCC tumor less than 4 months ago and am planning radiation therapy.
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I have another cancer type, but it won't affect this trial's treatment.
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I can receive immunotherapy before, during, or after radiation therapy.
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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.
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I agree to use birth control during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To establish the 2-year local control rate for adjuvant hypofractionated RT to the primary tumor bed. And to establish the 2-year nodal control rate for adjuvant hypofractionated RT to the primary draining nodal bed.

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 GI: NOS
12%
Late RT Toxicity: Other: 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%
Nausea
2%
Hyperglycemia NOS
2%
Depression NEC
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Stomatitis
1%
Blood albumin decreased
1%
Platelet count decreased
1%
Weight decreased
1%
Anorexia
1%
Hypocalcemia
1%
Hyponatremia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus Chemotherapy

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
2,962 Previous Clinical Trials
1,803,313 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA ratified radiation therapy as a viable treatment?

"Owing to the second-phase nature of this trial, which has produced data indicating safety but not efficacy, our team at Power estimated Radiation therapy's security rating as a 2."

Answered by AI

Are there any opportunities for participants to join this experiment?

"Clinicaltrials.gov indicates that this medical trial is currently enlisting patients, with the posting date being December 14th 2021 and the most recent modification occurring on February 3rd 2022."

Answered by AI

What is the aggregate figure of individuals involved in this research project?

"Affirmative. The information displayed on clinicaltrials.gov confirms that the medical study, which was first posted on December 14th 2021, is actively searching for patients. Approximately 52 participants need to be found from a single healthcare facility."

Answered by AI
~34 spots leftby Sep 2028