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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Proton radiotherapy
RadiationProton radiotherapy
Photon radiotherapy
RadiationConventional photon radiotherapy
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Photon radiotherapyActive comparator 1 intervention
Group B: Proton radiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute grade >2 hematological side effects
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.
Time frame
Treatment start until three months after treatmentSecondary outcomes
1
Acute grade >2 gastrointestinal side effects
Acute side-effects from the gastrointestinal tract are assess the NTCAE v5.0 scoring system by using. Patient reported side effects are assessed by the European Organization for Research and Treatment of Cancer (EORTC), disease specific quality of life questionnaire for anal cancer, (QLQ-ANL27). During radiotherapy, daily reported symptoms will be investigated by a newly developed symptom scale, Radiotherapy related symptom assessment scale (RSAS). The questionnaire includes 13 items specific for current diagnose. The RSAS is a validated instrument for assessing symptom intensity and distress in patients with different cancer disease undergoing radiotherapy, with psychometric properties within the expected range. Answering categories ranges from not at all to a great deal (1-4).
Time frame
Treatment start until three months after treatment2
Acute side effects from skin
Acute side-effects from skin are assessed by using the Common Terminology Criteria for Adverse Events (NTCAE) v5.0 scoring system. Patient reported side effects are assessed by the European Organization for Research and Treatment of Cancer (EORTC), disease specific questionnaire, QLQ-ANL27. During radiotherapy, daily reported symptoms will be investigated by a newly developed symptom scale, Radiotherapy related symptom assessment scale (RSAS). The questionnaire includes 13 items specific for current diagnose. The RSAS is a validated instrument for assessing symptom intensity and distress in patients with different cancer disease undergoing radiotherapy, with psychometric properties within the expected range. Answering categories ranges from not at all to a great deal (1-4).
Time frame
Treatment start until three months after treatment3
Acute side effects from the genitourinary tract
Acute side-effects from the genitourinary tract are assessed by scoring of genitourinary symptoms, pain by using the Common Terminology Criteria for Adverse Events (NTCAE) v5.0 scoring system. Patient reported side effects are assessed by the European Organization for Research and Treatment of Cancer (EORTC), disease specific questionnaire, QLQ-ANL27. During radiotherapy, daily reported symptoms will be investigated by a newly developed symptom scale, Radiotherapy related symptom assessment scale (RSAS). The questionnaire includes 13 items specific for current diagnose. The RSAS is a validated instrument for assessing symptom intensity and distress in patients with different cancer disease undergoing radiotherapy, with psychometric properties within the expected range. Answering categories ranges from not at all to a great deal (1-4).
Time frame
Treatment start until three months after treatment4
Pain due to acute radiation reaction
Pain is assessed by using the NTCAE v5.0 scoring system. Patient reported pain is assessed by the European Organization for Research and Treatment of Cancer (EORTC), disease specific questionnaire, QLQ-ANL27. During radiotherapy, daily reported symptoms will be investigated by a newly developed symptom scale, Radiotherapy related symptom assessment scale (RSAS). The questionnaire includes 13 items specific for current diagnose. The RSAS is a validated instrument for assessing symptom intensity and distress in patients with different cancer disease undergoing radiotherapy, with psychometric properties within the expected range. Answering categories ranges from not at all to a great deal (1-4).
Time frame
Treatment start until three months after treatmentOther outcomes
1
Cost-utility analysis
Costs and QoL as well as clinical outcome measured as survival time will be considered. The results of the health-economic part of the study will be expressed as cost per quality adjusted life years (QALYs) saved of one intervention in comparison with the other. All relevant costs should be identified, quantified, and valued. Also indirect costs related to loss of production when patients cannot work due to the disease. All types of resources associated with the two treatment arms during the follow-up should be considered. E.g. costs for treatment of side-effects, costs for surgery when performed, and travelling costs for patients. Costing will be performed at the end of the study. For evaluation and analysis of the study results, a relatively simple health-economic model will be developed. This model will be used for evaluation of the two treatment arms from inclusion into the study until 5 years of follow up or death.
Time frame
From randomisation until 5 years or deathSponsors and contacts
Click on the lead sponsor to view all of their trials.
Umeå University
Lead sponsor
Region Västerbotten
Collaborator
Uppsala County Council, Sweden
Collaborator
Source ClinicalTrials.gov