Hypofractionated Radiation Therapy for Merkel Cell Carcinoma

NCT05100095 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2021-0789NCI-2021-12100
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Merkel Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 2 year

Study Arms (1)

Radiation therapy

EXPERIMENTAL

Patients receive radiation therapy in 10 daily fractions (M-F) over 2 weeks.

Drug: Radiation therapy

Interventions

Radiation therapy DRUG

Hypofractionated radiation therapy to the primary tumor and/or lymph nodes

Radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed MCC.
• Patients must have no evidence of distant metastasis as determined by clinical examination and any form of imaging.
• If planned for adjuvant primary tumor radiation therapy a patient should have had surgical excision of a primary MCC tumor within 4 months of starting RT.
• 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 (receipt of neoadjuvant immunotherapy, ECE, \>1 involved node, \>1 cm nodal disease).
• Immunotherapy is permitted at any time and may specifically be administered prior to RT, concurrent with RT or after RT.
• Age ≥18 years because MCC is extremely rare in patients \<18 years of age and RT is considered high risk in this population due to risk of secondary malignancy and potentially growing tissues that may be adversely impacted by RT.
• ECOG performance status ≤3.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of RT.
• Ability to understand and the willingness to sign a written informed consent document.
• Expansion cohort
• Patient would have received \<50.4 Gy using conventional radiotherapy dose-fractionation if not enrolled.

You may not qualify if:

• 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. In other words, treatment on this trial would require re-irradiation of tissues.
• Patients with distant metastases
• Pregnant women are excluded from this study because RT is a known teratogen.
• Patients who are less than 18 years of age becase RT is extremely rare in this population and the treatment agent is a known carcinogen.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma, Merkel Cell

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Devarati Mitra

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Devarati Mitra

CONTACT

(713) 563-1339; dmitra@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 29, 2021
• Study Start: December 14, 2021
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (1)