Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-25 @ 12:42 PM
Study NCT ID:
NCT05100095
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2021-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypofractionated Radiation Therapy for Merkel Cell Carcinoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Hypofractionated Radiation Therapy for Merkel Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests whether hypofractionated radiation works to treat patients with Merkel cell carcinoma. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a fewer number of days than tradition radiation therapy courses for Merkel cell carcinoma. This may be less suppressive of the immune response to tumors and should be helpful for patient convenience.
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-12100 | OTHER | NCI-Clinical Trials Reporting | View |