NCT04462042 Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma
| NCT ID | NCT04462042 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Umeå University |
| Condition | Anal Cancer Squamous Cell |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-04-07 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2021-04-07 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Nina Cavalli Björkman, MD
PRINCIPAL INVESTIGATOR
Uppsala University Hospital
Frequently Asked Questions
Who can join the NCT04462042 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anal Cancer Squamous Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04462042 currently recruiting?
Yes, NCT04462042 is actively recruiting participants. Contact the research team at bjorn.zackrisson@umu.se for enrollment information.
Where is the NCT04462042 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Lund, Sweden, Umeå, Sweden, Uppsala, Sweden.
Who is sponsoring the NCT04462042 clinical trial?
NCT04462042 is sponsored by Umeå University. The principal investigator is Nina Cavalli Björkman, MD at Uppsala University Hospital. The trial plans to enroll 100 participants.
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