Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer

Официальное название

TNT-RECORD:Total Neoadjuvant Treatment in Rectal Cancer With On-couch Adaptive Radiotherapy

Обзор

Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment). This study therefore investigates the benefit of on-couch adaptation for locally advanced rectal cancer patients undergoing this treatment regime.

Подробное описание

This is a prospective single-arm study investigating the benefit of on-couch adaptation for locally advanced rectal cancer patients prescribed with pre-operative sequential short-course radiotherapy (RT) followed by Oxaliplatin-combined chemotherapy (mFOLFOX(6) or CAPOX). On-couch adaptation, where the radiation dose is tailored to the anatomy of the patient at each radiotherapy session. Firstly, the study will investigate if on-couch adaptation result in less gastro-intestinal adverse events, secondly it will reveal if this possible reduction lead to more patients being able to fulfill all cycles of prescribed chemotherapy.

Вмешательства

• Лучевая терапия On-couch adaptive radiotherapy
  A new treatment plan, guided by volumetric images, is created at each treatment session

Первичные конечные точки

• Incidence of acute gastro-intestinal toxicity equal or higher than grade 2 [Срок оценки: Up to administration of the last course of chemotherapy or week 22, whichever comes first]

Вторичные конечные точки (6)

• Number of participants that require alteration of chemotherapy due to toxicity [Срок оценки: From treatment week 3 up to week 20]
• Number of patients with disease related treatment failure [Срок оценки: 5 years after surgery]
• Number of patients with pathological complete response (pCR) [Срок оценки: At surgery i.e. in treatment week 23-28]
• Tumour regression grade [Срок оценки: Baseline to response evaluation on MR in up to week 25 of the study]
• Overall survival [Срок оценки: Follow-up until 5 years or death]
• Incidence of late gastro-intestinal toxicity equal or higher than grade 2 [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Patients with loco-regional advanced rectal adenocarcinoma with clinical indications for short-course with TNT chemotherapy i.e. having at least one of the following T4a, CRM+ (≤1 mm), N1c, N2 or extramural vascular invasion (EMVI+). Patients presenting at least one of these criteria in addition to involvement of the pelvic sidewall lymph nodes (PSW) can optionally be considered.
• ECOG status ≤ 1
• Being willing and able to give full written consent for participation

Критерии исключения

• Previous rectal cancer treatment
• Previous irradiation to the treatment area e.g. prostate cancer
• Hip prosthesis
• Contraindications to MRI
• Pregnancy
• Abnormal DPYD genotype
• Known contraindication to 5-FU, Capecitabine or Oxaliplatin as judged by the investigators

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Норвегия · 1 центр

• Haukeland University Hospital — Bergen

Идентификаторы

NCT: NCT05883800 · 402056

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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