Hypofractionated Radiation Therapy for Merkel Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT05100095|
Recruitment Status : Recruiting
First Posted : October 29, 2021
Last Update Posted : September 7, 2023
|Condition or disease||Intervention/treatment||Phase|
|Merkel Cell Carcinoma||Drug: Radiation therapy||Phase 2|
- 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.
- 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 (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hypofractionated Radiation Therapy for Merkel Cell Carcinoma|
|Actual Study Start Date :||December 14, 2021|
|Estimated Primary Completion Date :||September 1, 2028|
|Estimated Study Completion Date :||September 1, 2028|
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
- 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 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05100095
|Contact: Devarati Mitra||(713) firstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Devarati Mitra 713-563-1339 email@example.com|
|Principal Investigator:||Devarati Mitra||M.D. Anderson Cancer Center|