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NCT04462042Recruiting

Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma

Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma - Swedish Anal Carcinoma Study

Source: ClinicalTrials.gov · Last updated 3 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
24 Jun 2020
Start date
7 Apr 2021
Primary completion date
1 Apr 2026
Lead sponsor
Umeå University
NCT number
NCT04462042

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 7 Apr 2021 to the primary completion date, 1 Apr 2026
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient judged to have any other treatment than radiotherapy with concomitant chemotherapy as the preferred treatment
  • Previous radiotherapy, surgery or chemotherapy that may interfere with the planned treatment for the present disease, as judged by the investigator.
  • When prosthetic materials (e.g. hip prostheses) are present close to the target volume it must be considered if this may introduce uncertainties in dose calculations that precludes especially, proton therapy.

Other illness

  • Patients with cancer of the perianal skin without involvement of the anal canal (ICD-O-3 C44.5) are not eligible.
  • Concomitant or previous malignancies. Exceptions are, adequately treated basal cell carcinoma or squamous cell carcinoma of the skin or, other previous malignancy with a disease-free interval of at least 5 years.
  • Two or more synchronous primary cancers in the pelvic region at time of diagnosis

Age

  • Co-existing disease prejudicing survival (expected survival should be \>2 years).

Other

  • Pregnancy or breast feeding
  • Patients with pacemaker/ICD are not eligible.

Who the study is looking for

  • The patient must be at least 18 years old
  • Histologically confirmed, previously untreated squamous cell carcinoma (p16-positive or p16-negative) of the anal canal (ICD-O-3 C21), i.e. cancer of the perianal skin without connection to the anal canal are not included. The patients may have primary tumour, regional nodes, metastasis (TNM)-stage T2 (\>4 cm) -4,N0-1c,M0 (UICC 8th edition).
  • World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG) performance status 0-1
  • The patient must be able to understand the information about the treatment and give a written informed consent.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sahlgrenska University Hospital
Coordinator of this site? Confirm its status
GothenburgSwedenRecruiting
Lund University Hospital
Coordinator of this site? Confirm its status
LundSwedenRecruiting
Umeå University Hospital
Coordinator of this site? Confirm its status
UmeåSwedenRecruiting
Uppsala University Hospital
Coordinator of this site? Confirm its status
UppsalaSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.