Hypofractionated Radiation Therapy for Merkel Cell Carcinoma
ConditionMerkel Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Prior positive sentinel lymph node biopsy with any degree of nodal involvement within 4 months of starting RT and no completion nodal dissection, or
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Radiation therapy
DrugHypofractionated radiation therapy to the primary tumor and/or lymph nodes
Treatment groups
52 Participants
are divided into 1 treatment groupGroup A: Radiation therapyExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
through study completion, an average of 2 yearSponsors and contacts
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Source ClinicalTrials.gov