Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma

Anal Cancer Squamous Cell Clinical Trial

— SWANCA  

Official title:

Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma - Swedish Anal Carcinoma Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04462042
• Other study ID #: SWANCA
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2021
• Est. completion date: March 28, 2030

Study information

• Verified date: December 2023
• Source: Umeå University
• Contact: Björn U Zackrisson, MD
• Phone: +46907850000
• Email: bjorn.zackrisson[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 28, 2030
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal Cancer Squamous Cell
• Anus Neoplasms
• Carcinoma, Squamous Cell

Intervention

Radiation:
• Proton radiotherapy
Proton radiotherapy
• Photon radiotherapy
Conventional photon radiotherapy

Locations

Country	Name	City	State
Sweden	Umeå university hospital	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Region Västerbotten

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	From randomisation until 5 years or death
Primary	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.	Treatment start until three months after treatment
Secondary	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).	Treatment start until three months after treatment
Secondary	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).	Treatment start until three months after treatment
Secondary	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).	Treatment start until three months after treatment
Secondary	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).	Treatment start until three months after treatment
Secondary	Late side effects from the gastro-intestinal system	Late side effects 1, 2 and 5 years after completion of treatment. Side effects from the gastrointestinal system, are assessed by using the NTCAE v5.0 scoring system. Patient reported side effects are assessed by the EORTCs disease specific questionnaire, QLQ-ANL27.	From three months after treatment up to five years after treatment
Secondary	Late side effects	Late side effects 1, 2 and 5 years after completion of treatment. Side effects from the genitourinary system are assessed by using the NTCAE v5.0 scoring system. Patient reported side effects are assessed by the EORTCs disease specific questionnaire, QLQ-ANL27.	From three months after treatment up to five years after treatment
Secondary	Late side effects from skin	Late side effects 1, 2 and 5 years after completion of treatment. Side effects from the skin are assessed by using the NTCAE v5.0 scoring system. Patient reported side effects are assessed by the EORTCs disease specific questionnaire, QLQ-ANL27.	From three months after treatment up to five years after treatment
Secondary	Assessment of Quality of life (QoL)	Patient reported quality of life during and after treatment assessed by • HRQoL will be investigated with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, the QLQ-C30, supplemented by the disease specific module (anal-cancer) QLQ-ANL27. • EuroQol (EQ-5D) is a generic QoL instrument designed for self-administration. The result could be expressed as a weight with values between zero and one (0-1). Together with information about survival the QoL weight can be expressed as quality-adjusted life-years (QALYs).	From randomisation up to 5 years
Secondary	Primary tumour response	Frequency of complete tumour regression after primary treatment	3-6 months after treatment
Secondary	Locoregional failure	Time from randomisation until first recurrence, local and/or regional	Up to five years after randomisation
Secondary	Disease free survival	Time from randomisation until first recurrence, local/regional/systemic or death	Up to five years after randomisation
Secondary	Overall survival	Time from randomisation until death	Up to five years after randomisation