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

Sponsor
Fudan University
Study ID
NCT06652412
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ultrafractionated RT and CGA Guided systemic treatment. — DRUG
    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.
  • data prospectively collected — OTHER
    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.
  • Ultrafractionated Radiotherapy — RADIATION
    1Fx every 3 or 4weeks
  • Sintilimab — DRUG
    200 mg q3w
  • Fluorouracil — DRUG
    5-Fluorouracil or capecitabine
  • Raltitrexed — DRUG
    Raltitrexed
  • Oxaliplatin — DRUG
    Oxaliplatin
  • Irinotecan (CPT-11) — DRUG
    irinotecan

Study Details

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.

Key Dates

Start date
Nov 30, 2024
Status verified
Oct 2024
Primary completion
Nov 30, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
124 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CGA cohort
    in cohort 1, all patients will receive Ultrafractionated RT, PD-1 antibody, and Comprehensive Geriatric Assessment (CGA) Guided systemic treatment. 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 single agent chemotherapy and BSC; Fit patients will receive doublet chemotherapy and BSC.
  • Other: external control cohort
    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.

Primary Outcome Measure

Complete response (CR) rate [ Time Frame: 1 month after the surgery or the decision of W&W ]

Central Contacts

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