Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proton radiotherapy, Photon radiotherapy.
- Who it may be relevant to
- Registry conditions: Anal Cancer Squamous Cell. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma - Swedish Anal Carcinoma Study
Overview
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.
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 have the potential to decrease the incidence/severity of some acute side effects from certain organs at risk e.g. bone marrow and intraperitoneal bowel. By sparing the dose to these organs it is also possible that late effects might be less evident. Sparing of the bone marrow may lead to fewer septic events and dose reductions of chemotherapy which may, as a consequence, improve tumour control. The primary aim of this study is to find ways to decrease acute side effects primarily to alleviate some discomfort from the patient during and after a usually painful treatment experience. It has also been concluded by others that reduction of acute side effects is a relevant aim and end point for the evaluation of new treatment techniques and both patient reported and physician reported data are assessed
Interventions
- Radiation Proton radiotherapy
Proton radiotherapy - Radiation Photon radiotherapy
Conventional photon radiotherapy
Primary outcome measures
- Acute grade >2 hematological side effects [Time frame: Treatment start until three months after treatment]
Secondary outcome measures (12)
- Acute grade >2 gastrointestinal side effects [Time frame: Treatment start until three months after treatment]
- Acute side effects from skin [Time frame: Treatment start until three months after treatment]
- Acute side effects from the genitourinary tract [Time frame: Treatment start until three months after treatment]
- Pain due to acute radiation reaction [Time frame: Treatment start until three months after treatment]
- Late side effects from the gastro-intestinal system [Time frame: From three months after treatment up to five years after treatment]
- Late side effects [Time frame: From three months after treatment up to five years after treatment]
- Late side effects from skin [Time frame: From three months after treatment up to five years after treatment]
- Assessment of Quality of life (QoL) [Time frame: From randomisation up to 5 years]
- Primary tumour response [Time frame: 3-6 months after treatment]
- Locoregional failure [Time frame: Up to five years after randomisation]
- Disease free survival [Time frame: Up to five years after randomisation]
- Overall survival [Time frame: Up to five years after randomisation]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 4 centers
- Sahlgrenska University Hospital — Gothenburg
- Lund University Hospital — Lund
- Umeå University Hospital — Umeå
- Uppsala University Hospital — Uppsala
Identifiers
NCT: NCT04462042 · SWANCA