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NOT YET RECRUITING
NCT06652412
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2024-11

Completion Date

2028-11

Last Updated

2024-10-28

Healthy Volunteers

No

Interventions

DRUG

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.

OTHER

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.

RADIATION

Ultrafractionated Radiotherapy

1Fx every 3 or 4weeks

DRUG

Sintilimab

200 mg q3w

DRUG

Fluorouracil

5-Fluorouracil or capecitabine

DRUG

Raltitrexed

Raltitrexed

DRUG

Oxaliplatin

Oxaliplatin

DRUG

Irinotecan (CPT-11)

irinotecan