NCT05100095

Hypofractionated Radiation Therapy for Merkel Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests whether hypofractionated radiation works to treat patients with Merkel cell carcinoma. Radiation therapy uses high energy radio waves to kill cancer cells and shrink tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may be more convenient for patients and less immunosuppressive.

Detailed description

* To estimate the 2-year local control rate for adjuvant hypofractionated RT to the primary tumor bed. * To estimate the 2-year nodal control rate for adjuvant hypofractionated RT to the primary draining nodal basin. Secondary Objectives * To determine MCC disease outcomes including:time to non-nodal locoregional recurrence, time to nodal recurrence, time to distant mestasis, disease-free-survival and disease-specific survival for patients receiving hypofractionated adjuvant RT. * To assess acute and late RT associated toxicity within or neighboring the radiated field.

Conditions

• Merkel Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Radiation therapy	Hypofractionated radiation therapy to the primary tumor and/or lymph nodes

Timeline

• Start date: 2021-12-14
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2021-10-29
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study