Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04462042

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma | DecenTrialz