CGA Guided Ultrafractionated RT and Systemic Treatment in Elderly or Frail Patients with Inoperable Localized CRC

Официальное название

Comprehensive Geriatric Assessment (CGA) Guided Ultrafractionated Radiotherapy and Systemic Treatment in Elderly or Frail Patients with Inoperable Localized Colorectal Cancer

Обзор

This is a prospective, multicentre, cohort study. For cohort 1, experimental cohort, older or Frail patients with inoperable localized colorectal cancer will receive Ultrafractionated Radiotherapy (RT) and Comprehensive Geriatric Assessment (CGA) Guided systemic treatment. All patients will receive Ultrafractionated RT and PD-1 antibody. Furthermore, CGA will assess all patients and classify them into Frail, Vulnerabe, or Fit. Frail patients will receive Best Supportive Care (BSC); Vulnerabe patients will receive Fluorouracil/Raltitrexed and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC. For cohort 2, external control from real word, data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected. The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus clinical complete response \[cCR\]) rate. The secondary endpoints include the grade 3-4 acute adverse effects rate, anal preservation rate, survival etc.

Подробное описание

This is a prospective, multicentre, cohort study. For cohort 1, experimental cohort, older or Frail patients with inoperable localized colorectal cancer will receive Ultrafractionated Radiotherapy (RT) and Comprehensive Geriatric Assessment (CGA) Guided systemic treatment. All patients will receive Ultrafractionated RT and PD-1 antibody. Furthermore, CGA will assess all patients and classify them into Frail, Vulnerabe, or Fit. Frail patients will receive Best Supportive Care (BSC); Vulnerabe patients will receive Fluorouracil/Raltitrexed and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC.

For cohort 2, external control from real word, data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected.

The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus clinical complete response \[cCR\]) rate. The secondary endpoints include the grade 3-4 acute adverse effects rate, anal preservation rate, 1-year DFS rate, 1-year DSS rate, 1-year OS rate etc.

Вмешательства

• Препарат Ultrafractionated RT and CGA Guided systemic treatment.
  in cohort 1, all patients will receive Ultrafractionated RT (1Fx every 3 or 4weeks) and Sintilimab (q3w). Furthermore, CGA will assess all patients and classify them into Frail, Vulnerabe, or Fit. Frail patients will receive Best Supportive Care (BSC); Vulnerabe patients will receive Fluorouracil/Raltitrexed and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC.
• Другое data prospectively collected
  in cohort 2, external control from real word, data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected.
• Лучевая терапия Ultrafractionated Radiotherapy
  1Fx every 3 or 4weeks
• Препарат Sintilimab
  200 mg q3w
• Препарат Fluorouracil
  5-Fluorouracil or capecitabine
• Препарат Raltitrexed
  Raltitrexed
• Препарат Oxaliplatin
  Oxaliplatin
• Препарат Irinotecan (CPT-11)
  irinotecan

Первичные конечные точки

• Complete response (CR) rate [Срок оценки: 1 month after the surgery or the decision of W&W]

Вторичные конечные точки (7)

• Grade 3-4 adverse effects rate [Срок оценки: From date of randomization until 3 months after the completion neoadjuvant therapy]
• 1 year anal preservation rate [Срок оценки: From date of randomization until the date of or date of death from any cause, whichever came first, assessed up to 12 months.]
• health-related quality of life (HRQOL) [Срок оценки: baseline, and at 3, 6 and 12 months.]
• 1 year disease free survival rate [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.]
• 1 year local recurrence free survival rate [Срок оценки: From date of randomization until the date of first documented pelvic failure, assessed up to 12 months.]
• 1 year Disease-specific survival rate [Срок оценки: From date of randomization until the date of death from the specific disease, assessed up to 12 months.]
• 1 year overall survival rate [Срок оценки: From date of randomization until the date of death from any cause, assessed up to 12 months.]

Критерии участия

Критерии включения

• ≥70y, or, ≥60 and <70y but ECOG≥2;
• male or female;
• Pathologically confirmed Colorectal adenocarcinoma;
• any distance from anal verge;
• Clinical stage ≥T2 and/or N+, without distance metastases;
• refuse radical operation, physiologically or technically inoperable;
• No previous radiotherapy in the same field；
• No chemotherapy prior to enrollment;
• No immunotherapy prior to enrollment;
• With good compliance during the study
• Signed written informed consent

Критерии исключения

• Known history of other malignancies within 3 years，except cured skin cancer, cervical cancer in situ or thyroid carcinoma.
• Individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders that, in the judgment of the investigator, are of such clinical severity that they may prevent the signing of an informed consent form or affect the patient's adherence to oral medications
• Individuals with clinically serious (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months
• Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy
• Individuals with autoimmune diseases
• Individuals with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases
• Baseline hematology and biochemistry did not meet the following criteria: Hb≥90g/L; NEU ≥1.5×109/L; PLT ≥100×109/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; TB <1.5 times the upper limit of normal; Cr <1 time the upper limit of normal; Alb ≥30g/L
• Individuals allergic to any drug component of the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06652412 · FDRT-2024-137-3690

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗