Hypofractionated Radiation Therapy for Merkel Cell Carcinoma

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.

Study Overview

• Status: Recruiting
• Conditions: Merkel Cell Carcinoma
• Intervention / Treatment: Drug: Radiation therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Devarati Mitra; Phone Number: (713) 563-1339; Email: dmitra@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Devarati Mitra; Phone Number: 713-563-1339; Email: dmitra@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• RT is a known teratogen. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (refer to MDA Policy CLN 1114) This includes all female patients, between the onset of menses and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: • Postmenopausal (no menses in greater than or equal to 12 consecutive months). • History of hysterectomy or bilateral salpingo-oophorectomy. • Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). • History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiation therapy; Patients receive radiation therapy in 10 daily fractions (M-F) over 2 weeks.	Drug: Radiation therapy; Hypofractionated radiation therapy to the primary tumor and/or lymph nodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Devarati Mitra, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2021
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Infections; Virus Diseases; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; DNA Virus Infections; Carcinoma; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Tumor Virus Infections; Polyomavirus Infections; Carcinoma, Neuroendocrine; Carcinoma, Merkel Cell; Therapeutics; Radiotherapy
• Other Study ID Numbers: 2021-0789; NCI-2021-12100 (Other Identifier: NCI-Clinical Trials Reporting)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No