Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma
ConditionAnal Cancer Squamous Cell
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUmeå University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Proton radiotherapy
- Photon radiotherapy
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Umeå University
Lead sponsor
Region Västerbotten
Collaborator
Uppsala County Council, Sweden
Collaborator
Source ClinicalTrials.gov