Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630793
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-04-19
Brief Title:
IMRT Versus IMPT With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase III Randomised Control Trial of Intensity-Modulated Radiotherapy Using Photon Versus Proton With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPAC
Brief Summary:
The standard practice in management of carcinoma of anal canal is to treat patients with radiotherapy using the IMRT technique along with chemotherapy It is known that while IMRT has reduced treatment related side effects as compared to the older radiation techniques reducing these side effects further still remains a major challenge
These side-effects include gastrointestinal diarrhea altered bowel habits weight loss bleeding obstruction genitourinary difficulties in passing urine passing blood in urine difficulty in holding urine and hematologic toxicities anemia low platelet count and increased predisposition to infections
Proton therapy IMPT is a form of radiation treatment in which high doses can be delivered within the tumor while the surrounding normal tissues receive a lesser radiation dose It is believed that these physical properties of proton therapy may help reduce the side effects of treatment
Patients will be randomly assigned to either receive IMRT or IMPT based treatment so as to see whether it is possible to reduce the acute treatment related toxicities In this study there is a 667 chance that the patient will get IMPT based treatment which may be able to reduce the toxicities
These side-effects include gastrointestinal diarrhea altered bowel habits weight loss bleeding obstruction genitourinary difficulties in passing urine passing blood in urine difficulty in holding urine and hematologic toxicities anemia low platelet count and increased predisposition to infections
Proton therapy IMPT is a form of radiation treatment in which high doses can be delivered within the tumor while the surrounding normal tissues receive a lesser radiation dose It is believed that these physical properties of proton therapy may help reduce the side effects of treatment
Patients will be randomly assigned to either receive IMRT or IMPT based treatment so as to see whether it is possible to reduce the acute treatment related toxicities In this study there is a 667 chance that the patient will get IMPT based treatment which may be able to reduce the toxicities
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None