Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05838391
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-04-04
Brief Title:
Adaptive Radiation in Anal Cancer
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Feasibility Study of Adaptive Radiotherapy for the Treatment of Locally-Advanced Anal Squamous Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-07
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 is a 20 patient pilot study to examine the feasibility of dose-adapted radiation therapy for the treatment of locally advanced anal squamous cell cancer The tumor and a patients anatomy may change during radiation treatment and daily adaption of the radiation plan ie a new daily plan based on the anatomy of the day may help to maximize the dose to the tumor and minimize the radiation dose to the normal surrounding organs
Detailed Description:
The standard treatment for Human Papilloma Virus HPV-positive locally advanced anal cancer described as a tumor that is greater than 4 cm in size or with positive lymph nodes is 54 Gy of radiation treatment to the anal canal and primary tumor planning total volume PTV 504-54 Gy to positive nodal PTV and 45 Gy to elective lymph node PTV with 5-fluorouracil 5-FU and mitomycin-C chemotherapy administered at the same time as radiation in 30 fraction treatments delivery During the six week course of radiotherapy there is often a notable decrease in volume of the tumor both primary and regional nodes as early as one week into treatment detected on weekly on-board Cone Beam Computed Tomography CBCT which is a scan done on the treatment machine while patients receive radiation to ensure that the tumor is being treated and normal tissue is not However CT simulation a CT scan used to plan radiation treatment and re-planning of the treatment to account for the tumor shrinkage are not routinely performed due to time patient inconvenience and staffing resources As such daily adaptive radiation which can generate a new CT-based plan using the anatomy of the day may be a time efficient method to both plan and treat the patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None