Comparing Proton and Photon Therapy for Anal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the side effects of proton beam therapy versus photon therapy in patients with anal squamous cell carcinoma. It is a randomized controlled trial that evaluates the potential of proton therapy to reduce both acute and late side effects associated with treatment. By sparing critical organs at risk, such as bone marrow and intraperitoneal bowel, the study seeks to improve patient comfort and treatment outcomes. Patient-reported and physician-reported data will be collected to assess the effectiveness of these treatment modalities.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The patient must be at least 18 years old
2. 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).
3. World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG) performance status 0-1
4. The patient must be able to understand the information about the treatment and give a written informed consent.

Exclusion Criteria:

1. Patients with cancer of the perianal skin without involvement of the anal canal (ICD-O-3 C44.5) are not eligible.
2. Patient judged to have any other treatment than radiotherapy with concomitant chemotherapy as the preferred treatment
3. 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.
4. Two or more synchronous primary cancers in the pelvic region at time of diagnosis
5. Previous radiotherapy, surgery or chemotherapy that may interfere with the planned treatment for the present disease, as judged by the investigator.
6. Co-existing disease prejudicing survival (expected survival should be \>2 years).
7. Pregnancy or breast feeding
8. 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.
9. Patients with pacemaker/ICD are not eligible.

Where it's running

• Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting
• Lund University Hospital
  Lund, Sweden Recruiting
• Umeå University Hospital
  Umeå, Sweden Recruiting
• Uppsala University Hospital
  Uppsala, Sweden Recruiting

Study contacts

• Principal investigator: Nina Cavalli Björkman, MD — Uppsala University Hospital
• Study coordinator: Björn U Zackrisson, MD
• Email: bjorn.zackrisson@umu.se
• Phone: +46907850000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.