Hypofractionated Radiation Therapy for Merkel Cell Carcinoma

This study is testing a type of radiation therapy called hypofractionated radiation therapy for people with Merkel cell carcinoma (a rare and aggressive type of skin cancer). This treatment uses high-energy radio waves to kill cancer cells, but it delivers higher doses over a shorter period of time, which might be more convenient for you. To join, you must have Merkel cell carcinoma that has not spread to distant parts of your body. If you are having radiation to the primary tumor, you must have had surgery to remove the tumor within 4 months of starting radiation. The researchers want to see how well this treatment controls the cancer in the treated area and nearby lymph nodes (small glands that are part of the immune system) over two years. The study is currently recruiting about 52 participants.

Study design: This is a Phase II interventional study, which means all participants will receive the hypofractionated radiation therapy. It aims to enroll about 52 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed through study completion, which is an average of two years, to assess local and nodal control rates.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Hypofractionated Radiation Therapy for Merkel Cell Carcinoma

Recruiting

PHASE2Ages 18+InterventionalTreatment

M.D. Anderson Cancer Center

~52 participants

Updated 2026-07-16 on ClinicalTrials.gov

What's tested:Radiation therapy

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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.

Measured over through study completion, an average of 2 year

Conditions

Merkel Cell Carcinoma

NCT05100095

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

M D Anderson Cancer Center
Houston, Texasstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Devarati Mitra · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Devarati Mitra

[email protected]

(713) 563-1339

Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial 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.through study completion, an average of 2 year

Trialytics