Actively Recruiting
Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma
Led by Umeå University · Updated on 2025-04-03
100
Participants Needed
4
Research Sites
520 weeks
Total Duration
On this page
Sponsors
U
Umeå University
Lead Sponsor
R
Region Västerbotten
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is at least 18 years old
- Histologically confirmed, previously untreated squamous cell carcinoma of the anal canal (p16-positive or p16-negative)
- Tumor stage T2 (>4 cm) to T4, N0-1c, M0 according to UICC 8th edition
- WHO/ECOG performance status of 0 or 1
- Able to understand treatment information and provide written informed consent
You will not qualify if you...
- Cancer of the perianal skin without involvement of the anal canal
- Planned treatment other than radiotherapy with concomitant chemotherapy
- Other active malignancies except adequately treated basal or squamous cell skin cancer or cancers disease-free for at least 5 years
- Two or more synchronous primary cancers in the pelvic region at diagnosis
- Previous radiotherapy, surgery, or chemotherapy that may interfere with planned treatment
- Co-existing diseases expected to limit survival to less than 2 years
- Pregnancy or breastfeeding
- Presence of prosthetic materials near the target volume that may affect proton therapy dose calculations
- Presence of pacemaker or implantable cardioverter defibrillator (ICD)
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
2
Lund University Hospital
Lund, Sweden
Actively Recruiting
3
Umeå University Hospital
Umeå, Sweden
Actively Recruiting
4
Uppsala University Hospital
Uppsala, Sweden
Actively Recruiting
Research Team
B
Björn U Zackrisson, MD
CONTACT
M
Martin P Nilsson, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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