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Hypofractionated radiation therapy for Mucosal Melanoma of the Head and Neck

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Washington University School of Medicine, Saint Louis, MOMucosal Melanoma of the Head and NeckHypofractionated radiation therapy - Radiation
Eligibility
Any Age
All Sexes
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Study Summary

This trial is testing a new cancer treatment combining hypofractionated radiotherapy (HRT) with pembrolizumab. The goal is to see if this new treatment is more effective than HRT alone in controlling the tumor. Safety will also be monitored.

Eligible Conditions
  • Mucosal Melanoma of the Head and Neck

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Lenvatinib, Pembrolizumab and Hypofractionated (Hypofx) External Beam Radiation Therapy (EBRT) Group
1
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Hypofractionated Radiation Therapy

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 1 year

1 year
Local tumor control rate
Month 13
Number of treatment-related grade 3 or greater adverse events
Month 48
Distant metastasis-free survival
Overall survival
Relapse-free survival (RFS)
Month 12
Number of treatment discontinuations due to treatment-related adverse events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Lenvatinib, Pembrolizumab and Hypofractionated (Hypofx) External Beam Radiation Therapy (EBRT) Group
1
Pembrolizumab Injection [Keytruda]
1
Hypofractionated Radiation Therapy

Side Effects for

50 mg/m2
100%Fatigue
67%Vision changes
33%Hypertension
33%Headache
33%Constipation
33%Nausea
33%Insomnia
33%Dry skin
33%Diarrhea
33%Anorexia
33%Alopecia
33%High ALT
33%Low Calcium
This histogram enumerates side effects from a completed 2014 Phase 1 trial (NCT00841555) in the 50 mg/m2 ARM group. Side effects include: Fatigue with 100%, Vision changes with 67%, Hypertension with 33%, Headache with 33%, Constipation with 33%.

Trial Design

1 Treatment Group

Pembrolizumab + Hypofractionated radiation therapy
1 of 1

Experimental Treatment

16 Total Participants · 1 Treatment Group

Primary Treatment: Hypofractionated radiation therapy · No Placebo Group · Phase 2

Pembrolizumab + Hypofractionated radiation therapyExperimental Group · 2 Interventions: Pembrolizumab, Hypofractionated radiation therapy · Intervention Types: Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Hypofractionated radiation therapy
2009
Completed Phase 1
~10

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,821 Previous Clinical Trials
2,280,992 Total Patients Enrolled
George Ansstas, M.D.Principal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
246 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 6 Total Inclusion Criteria

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References

Frequently Asked Questions

Are there long-term repercussions to Hypofractionated radiation therapy?

"While Phase 2 trials don't have data supporting efficacy, there is some evidence indicating that hypofractionated radiation therapy is safe." - Anonymous Online Contributor

Unverified Answer

How many volunteers are participating in this research project?

"That is correct. The trial, which began recruiting on May 29th 2020 and was last updated February 7th 2022, is looking for 16 patients from a single location." - Anonymous Online Contributor

Unverified Answer

What cancerous tumors does Hypofractionated radiation therapy usually target?

"Hypofractionated radiation therapy can be used to target and treat malignant neoplasms, unresectable melanoma, and microsatellite instability high." - Anonymous Online Contributor

Unverified Answer

Can new patients still sign up to participate in this research?

"The clinical trial is still recruiting patients, as seen on the website clinicaltrials.gov. The listing for this study was first posted on May 29th, 2020 and updated February 7th, 2022." - Anonymous Online Contributor

Unverified Answer

Are there any precedent studies that have used Hypofractionated radiation therapy?

"Right now, there are 1000 ongoing clinical trials for Hypofractionated radiation therapy. 122 of these studies are in Phase 3. The majority of these Houston-based trials originated in Texas but there are 36053 locations running similar studies." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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