Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma

Recruiting now · Not applicable

Conditions studied: Anal Cancer Squamous Cell

In brief

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.

Key facts

Study ID

NCT04462042

Run by

Umeå University

People needed

100

Starts

2021-04-07

Expected to finish

2031-03-28

Last updated by the study team

2025-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients with cancer of the perianal skin without involvement of the anal canal (ICD-O-3 C44.5) are not eligible.
• Patient judged to have any other treatment than radiotherapy with concomitant chemotherapy as the preferred treatment
• 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
• Previous radiotherapy, surgery or chemotherapy that may interfere with the planned treatment for the present disease, as judged by the investigator.
• Co-existing disease prejudicing survival (expected survival should be >2 years).
• Pregnancy or breast feeding
• 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.
• Patients with pacemaker/ICD are not eligible.

Where it is running

• Sahlgrenska University Hospital — Gothenburg, Sweden (enrolling)
• Lund University Hospital — Lund, Sweden (enrolling)
• Umeå University Hospital — Umeå, Sweden (enrolling)
• Uppsala University Hospital — Uppsala, Sweden (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.