Ireland
--:--IST
Recruiting Not applicable

Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma

NCT04462042 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2021-04-07
Last updated
2025-04-03

Condition(s) studied

Anal Cancer Squamous Cell

Investigational drug(s) / intervention(s)

Proton radiotherapyPhoton radiotherapy

Proton radiotherapy: Proton radiotherapy

Photon radiotherapy: Conventional photon radiotherapy

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Acute grade >2 hematological side effects — Treatment start until three months after treatment
    Acute hematological side effects will be assessed by weekly full blood cell counts during radiotherapy and the first three weeks after treatment completion. Side Grade \>2 acute GI and haematological side-effects during therapy and up to three weeks after the end of treatment. Thereafter, every six weeks for up to three months after treatment. Results will be graded according to the Common Terminology Criteria for Adverse Events (NTCAE) v5.0 scoring system. Haematological adverse events will also be assessed by registering febrile episodes during an after treatment as well as the frequency of chemotherapy dose reduction or delayed chemotherapy.

Trial sites (4)

FacilityCityRegionStatus
Sahlgrenska University Hospital Gothenburg Sweden Recruiting
Lund University Hospital Lund Sweden Recruiting
Umeå University Hospital Umeå Sweden Recruiting
Uppsala University Hospital Uppsala Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04462042 on ClinicalTrials.gov ↗ ← All trials in Sweden