Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Proton radiotherapy: Proton radiotherapy
Photon radiotherapy: Conventional photon radiotherapy
Study 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.
Eligibility
Primary outcome measure(s)
- Acute grade >2 hematological side effects — Treatment start until three months after treatment
Acute hematological side effects will be assessed by weekly full blood cell counts during radiotherapy and the first three weeks after treatment completion. Side Grade \>2 acute GI and haematological side-effects during therapy and up to three weeks after the end of treatment. Thereafter, every six weeks for up to three months after treatment. Results will be graded according to the Common Terminology Criteria for Adverse Events (NTCAE) v5.0 scoring system. Haematological adverse events will also be assessed by registering febrile episodes during an after treatment as well as the frequency of chemotherapy dose reduction or delayed chemotherapy.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | Sweden | Recruiting |
| Lund University Hospital | Lund | Sweden | Recruiting |
| Umeå University Hospital | Umeå | Sweden | Recruiting |
| Uppsala University Hospital | Uppsala | Sweden | Recruiting |
More Umeå University trials in Sweden
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04462042 on ClinicalTrials.gov ↗ ← All trials in Sweden