Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer

Официальное название

Simultaneous Boost in Neoadjuvant Radiotherapy for Rectal Cancer：A Phase 2, Randomized Controlled Study

Обзор

The goal of this clinical trial is to learn whether new adjuvant radiotherapy with gross tumor volume(GTV) escalated to 58.75 Gy can improve complete response (CR) rates compared with GTV dose of 50 Gy in adult patients (18-79 years) with locally advanced rectal adenocarcinoma (T3-T4/N+, M0) located ≤10 cm from the anal verge.The main questions it aims to answer are: 1. Does GTV simultaneously boost to 58.75 Gy/25f increase complete response (pCR or cCR) compared with 50 Gy/25f? 2. How do the two regimens differ in terms of progression-free survival (PFS), pelvic local control (LC), tumor regression grade (TRG), organ preservation, and treatment-related toxicity? Researchers will compare GTV 58.75 Gy/25f (experimental arm) versus GTV 50 Gy/25f (control arm) to see if dose escalation improves tumor response rate. Participants will: 1. Receive neoadjuvant radiotherapy with one of the two PGTV dose escalated regimens (with concurrent chemotherapy: oral capecitabine or XELOX). 2. Undergo restaging with imaging and clinical assessment before surgery or observation. 3. Proceed to total mesorectal excision (TME), local excision, or "watch-and-wait" strategy depending on treatment response and patient preference. 4. Be followed regularly with clinical exams, imaging, endoscopy, and laboratory tests to assess efficacy, safety, and long-term outcomes.

Вмешательства

• Лучевая терапия GTV 58.75 Gy/25 fractions(Simultaneous Integrated Boost)
  Patients will receive neoadjuvant long course radiotherapy using VMAT or IMAT with daily image guided. Gross tumor volume (GTV): A total dose of 58.75Gy delivered in 25 fractions using a simultaneous integrated boost approach; CTV: 45Gy/25f; Mesorectum lymph node(GTVnd1):58.75Gy/25f ; Lateral lymph node（GTVnd2）：60Gy/25f;
• Лучевая терапия GTV 50 Gy/25 fractions(Simultaneous Integrated Boost)
  Patients will receive neoadjuvant radiotherapy with GTV 50 Gy in 25 fractions , delivered with IMRT or VMAT technique. CTV: 45Gy/25f; Mesorectum lymph node(GTVnd1):58.75Gy/25f; Lateral lymph node（GTVnd2）
• Препарат Concurrent Chemotherapy
  Concurrent administration of capecitabine (825 mg/m² twice daily, 5 days per week) or XELOX regimen during radiotherapy.
• Процедура Total mesorectal excision (TME) surgery or non-operative management
  After treatment, patients will undergo restaging and proceed to total mesorectal excision (TME) or non-operative management ("watch-and-wait") depending on response and clinical assessment.

Первичные конечные точки

• CR [Срок оценки: 1 year]

Вторичные конечные точки (5)

• 3-year disease free suvival rate [Срок оценки: 3 years]
• 3-year local control rate [Срок оценки: 3 years]
• Tumor Regression Grade [Срок оценки: 1 year]
• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: 3 years]
• Organ Preservation Rate [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Age ≥18 and <80 years
• Histologically confirmed rectal adenocarcinoma
• Tumor located within 10 cm from the anal verge
• MRI staging: T3-T4 and/or N+, M0 (AJCC 8th edition)
• ECOG performance status 0-2
• Adequate bone marrow function: WBC ≥3×10⁹/L, ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L
• Adequate liver function: TBIL ≤1.5 × ULN, ALT/AST ≤2.5 × ULN
• Adequate renal function: Cr ≤1.5 × ULN or CCr ≥60 mL/min
• Signed informed consent

Критерии исключения

• Prior rectal cancer surgery
• Prior induction chemotherapy, immunotherapy, or pelvic radiotherapy
• History of other malignancies
• History of chronic colitis, ulcerative colitis, or nonspecific proctitis
• Pregnant or breastfeeding women
• Active infection or fever
• Severe uncontrolled comorbidities (e.g., unstable heart disease, renal disease, chronic hepatitis, uncontrolled diabetes, psychiatric disorders)
• Inability to comply with study protocol

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07200141 · I-25PJ2066

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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