Status:
RECRUITING
Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma
Lead Sponsor:
Umeå University
Collaborating Sponsors:
Region Västerbotten
Uppsala County Council, Sweden
Conditions:
Anal Cancer Squamous Cell
Eligibility:
All Genders
18+ years
Phase:
NA
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 c...
Detailed Description
Anal carcinoma is a disease in which modern therapy is reasonably successful in achieving tumour control/cure. Both acute and late side effects are substantial. Proton radiotherapy is hypothesised to ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 28 2031
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04462042
Start Date
April 7 2021
End Date
March 28 2031
Last Update
April 3 2025
Active Locations (4)
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1
Sahlgrenska University Hospital
Gothenburg, Sweden
2
Lund University Hospital
Lund, Sweden
3
Umeå University Hospital
Umeå, Sweden
4
Uppsala University Hospital
Uppsala, Sweden