Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma

NCT04462042 | Recruiting

• 1 other identifier: SWANCA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Anal Cancer Squamous Cell

Keywords

proton beam therapy; side effects

Outcome Measures

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.

  Treatment start until three months after treatment

Secondary Outcomes (12)

• Acute grade >2 gastrointestinal side effects

  Treatment start until three months after treatment

• Acute side effects from skin

  Treatment start until three months after treatment

• Acute side effects from the genitourinary tract

  Treatment start until three months after treatment

• Pain due to acute radiation reaction

  Treatment start until three months after treatment

• Late side effects from the gastro-intestinal system

  From three months after treatment up to five years after treatment

Other Outcomes (1)

• Cost-utility analysis

  From randomisation until 5 years or death

Study Arms (2)

Photon radiotherapy

ACTIVE COMPARATOR

Conventional photon radiation is delivered by volumetric arc therapy/intensity modulated radiotherapy/helical tomotherapy using simultaneous integrated boost (SIB) technique. The total dose to the primary tumour target and node metastases \>2 cm is 57.5 Gy in 27 fractions, one fraction/day, five fractions/week during 5.5 weeks. Node metastases up to 2 cm will receive 50.5 Gy in 27 fractions. Elective lymph nodes will receive a total dose of 41.6 Gy.

Radiation: Photon radiotherapy

Proton radiotherapy

EXPERIMENTAL

Proton radiation is delivered by spot scanning. Proton plans will be produced by single field optimisation/single field uniform dose or multifield optimisation/intensity modulated proton therapy using simultaneous integrated boost (SIB) technique. The total dose to the primary tumour target and node metastases \>2 cm is 57.5 Gy(RBE) in 27 fractions, one fraction/day, five fractions/week during 5.5 weeks. Node metastases up to 2 cm will receive 50.5 Gy(RBE) in 27 fractions. Elective lymph nodes will receive a total dose of 41.6 Gy(RBE).

Radiation: Proton radiotherapy

Interventions

Proton radiotherapy RADIATION

Proton radiotherapy

Also known as: Intensity modulated proton therapy (IMPT)

Proton radiotherapy

Photon radiotherapy RADIATION

Conventional photon radiotherapy

Also known as: Volumetric arc therapy (VMAT), Intensity modulated radiotherapy (IMRT), helical tomotherapy

Photon radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead
• Region Västerbotten: collaborator
• Uppsala County Council, Sweden: collaborator

Study Sites (4)

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Lund University Hospital

Lund, Sweden

RECRUITING

Umeå University Hospital

Umeå, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Nina Cavalli Björkman, MD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Björn U Zackrisson, MD

CONTACT

+46907850000; bjorn.zackrisson@umu.se

Martin P Nilsson, MD

CONTACT

+4640333011; martin.p.nilsson@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is an open label, multi-centre, randomised phase II study. 100 patients with anal carcinoma (including carcinoma of the perianal skin) will be randomised in 1:1 ratio to treatment delivered with photons or protons

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 8, 2020
• Study Start: April 7, 2021
• Primary Completion: April 1, 2026
• Study Completion (Estimated): March 28, 2031
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)