CGA Guided Ultrafractionated RT and First-line Systemic Treatment in Elderly or Frail Patients with MCRC

Summary

This is a prospective, multicentre, cohort study. For cohort 1(CGA cohort), experimental cohort, older or Frail patients with metastatic 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 single agent chemotherapy, with/without targeted therapy, and BSC; Fit patients will receive doublet chemotherapy, with/without targeted therapy, and BSC.

For cohort 2 (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.

The primary endpoint is Progression Free Survival (PFS). The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, quality of life (QoL), the Overall Response Rate (ORR), 1-year Disease-specific survival (DSS) rate, 1-year overall survival (OS) rate etc.

Conditions

• Colon Cancer
• Rectal Cancer

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, with/without targeted therapy, and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, with/without targeted therapy, and BSC.

RADIATION

Ultrafractionated Radiotherapy

1Fx every 3 or 4weeks

DRUG

PD-1 antibody

Sintilimab

DRUG

Chemotherapy (Fluorouracil)

5-Fluorouracil or capecitabine

DRUG

Chemotherapy (Raltitrexed)

Raltitrexed

DRUG

Chemotherapy (Oxaliplatin)

Oxaliplatin

DRUG

Chemotherapy (CPT-11)

Irinotecan

DRUG

Targeted Therapy (anti-VEGF)

anti-VEGF antibody

DRUG

Targeted Therapy (anti-EGFR)

anti-EGFR antibody

Sponsors & Collaborators

• Fudan University

  lead OTHER

Principal Investigators

• Zhen ZHANG Principal Investigator · Fudan University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-30

Primary Completion

2027-11-30

Completion

2028-11-30