Ignite Creation Date:
2024-05-06 @ 2:55 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04462042
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2020-06-24
Brief Title:
Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma
Sponsor:
Umeå University
Organization:
Umeå University
Study Overview
Official Title:
Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma - Swedish Anal Carcinoma Study
Status:
RECRUITING
Status Verified Date:
2023-12
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:
SWANCA
Brief Summary:
Dosimetric studies suggest that radiotherapy with protons has a potential to reduce side effects compared to treatment with photons for patients with anal carcinoma AC There are so far no studies comparing these treatment techniques in a randomised setting The aim of this study is to compare side effects following photon therapy versus proton therapy within the framework of a randomised controlled trial
Detailed Description:
Anal carcinoma is a disease in which modern therapy is reasonably successful in achieving tumour controlcure Both acute and late side effects are substantial Proton radiotherapy is hypothesised to have the potential to decrease the incidenceseverity of some acute side effects from certain organs at risk eg bone marrow and intraperitoneal bowel By sparing the dose to these organs it is also possible that late effects might be less evident Sparing of the bone marrow may lead to fewer septic events and dose reductions of chemotherapy which may as a consequence improve tumour control The primary aim of this study is to find ways to decrease acute side effects primarily to alleviate some discomfort from the patient during and after a usually painful treatment experience It has also been concluded by others that reduction of acute side effects is a relevant aim and end point for the evaluation of new treatment techniques and both patient reported and physician reported data are assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None