Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Лучевая терапия Proton radiotherapy
  Proton radiotherapy
• Лучевая терапия Photon radiotherapy
  Conventional photon radiotherapy

Первичные конечные точки

• Acute grade >2 hematological side effects [Срок оценки: Treatment start until three months after treatment]

Вторичные конечные точки (12)

• Acute grade >2 gastrointestinal side effects [Срок оценки: Treatment start until three months after treatment]
• Acute side effects from skin [Срок оценки: Treatment start until three months after treatment]
• Acute side effects from the genitourinary tract [Срок оценки: Treatment start until three months after treatment]
• Pain due to acute radiation reaction [Срок оценки: Treatment start until three months after treatment]
• Late side effects from the gastro-intestinal system [Срок оценки: From three months after treatment up to five years after treatment]
• Late side effects [Срок оценки: From three months after treatment up to five years after treatment]
• Late side effects from skin [Срок оценки: From three months after treatment up to five years after treatment]
• Assessment of Quality of life (QoL) [Срок оценки: From randomisation up to 5 years]
• Primary tumour response [Срок оценки: 3-6 months after treatment]
• Locoregional failure [Срок оценки: Up to five years after randomisation]
• Disease free survival [Срок оценки: Up to five years after randomisation]
• Overall survival [Срок оценки: Up to five years after randomisation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 4 центра

• Sahlgrenska University Hospital — Gothenburg
• Lund University Hospital — Lund
• Umeå University Hospital — Umeå
• Uppsala University Hospital — Uppsala

Идентификаторы

NCT: NCT04462042 · SWANCA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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