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

NCT ID: NCT06665087

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2028-11-30

Brief 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.

Detailed Description

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CGA cohort

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

Group Type: EXPERIMENTAL

Ultrafractionated RT and CGA Guided systemic treatment.

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

Ultrafractionated Radiotherapy

Intervention Type: RADIATION

1Fx every 3 or 4weeks

PD-1 antibody

Intervention Type: DRUG

Sintilimab

Chemotherapy (Fluorouracil)

Intervention Type: DRUG

5-Fluorouracil or capecitabine

Chemotherapy (Raltitrexed)

Intervention Type: DRUG

Raltitrexed

Chemotherapy (Oxaliplatin)

Intervention Type: DRUG

Oxaliplatin

Chemotherapy (CPT-11)

Intervention Type: DRUG

Irinotecan

Targeted Therapy (anti-VEGF)

Intervention Type: DRUG

anti-VEGF antibody

Targeted Therapy (anti-EGFR)

Intervention Type: DRUG

anti-EGFR antibody

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.

Group Type: OTHER

Chemotherapy (Fluorouracil)

Intervention Type: DRUG

5-Fluorouracil or capecitabine

Chemotherapy (Raltitrexed)

Intervention Type: DRUG

Raltitrexed

Chemotherapy (Oxaliplatin)

Intervention Type: DRUG

Oxaliplatin

Chemotherapy (CPT-11)

Intervention Type: DRUG

Irinotecan

Targeted Therapy (anti-VEGF)

Intervention Type: DRUG

anti-VEGF antibody

Targeted Therapy (anti-EGFR)

Intervention Type: DRUG

anti-EGFR antibody

Interventions

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.

Intervention Type: DRUG

Ultrafractionated Radiotherapy

1Fx every 3 or 4weeks

Intervention Type: RADIATION

PD-1 antibody

Sintilimab

Intervention Type: DRUG

Chemotherapy (Fluorouracil)

5-Fluorouracil or capecitabine

Intervention Type: DRUG

Chemotherapy (Raltitrexed)

Raltitrexed

Intervention Type: DRUG

Chemotherapy (Oxaliplatin)

Oxaliplatin

Intervention Type: DRUG

Chemotherapy (CPT-11)

Irinotecan

Intervention Type: DRUG

Targeted Therapy (anti-VEGF)

anti-VEGF antibody

Intervention Type: DRUG

Targeted Therapy (anti-EGFR)

anti-EGFR antibody

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. ≥70y, or, ≥60 and <70y but ECOG≥2;

2. male or female;

3. metastatic colorectal cancer;

4. at least one measurable leasion;

5. the primary lesion could be 1)previously resected, or 2) not resected or recurred, and not been previously irradiated;

6. no more than 10 lesions, and all the lesions could be safely irradiated.

7. life expectancy is more than 3 months;

8. no previous standard first-line anti-cancer treatment(including 5-FU/ Capecitabine/Raltitrexed, oxaliplatin, or irinotecan), or more than 6 months after perioperative chemotherapy;

9. No immunotherapy prior to enrollment;

10. With good compliance during the study;

11. Signed written informed consent.

Exclusion Criteria

1. Known history of other malignancies within 3 years，except cured skin cancer, cervical cancer in situ, thyroid carcinoma, or clinical controlled prostate cancer;

2. 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;

3. 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;

4. Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy;

5. Individuals with autoimmune diseases;

6. Individuals with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;

7. Baseline hematology and biochemistry did not meet the following criteria: Hb≥80g/L; NEU ≥1.5×109/L; PLT ≥100×109/L（PLT ≥80×109/L if there were liver metastasis）; 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;

8. Individuals allergic to any drug component of the study.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhen Zhang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhen ZHANG Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Central Contacts

Zhen ZHANG Principal Investigator

Role: CONTACT

zhen_zhang@fudan.edu.cn

18801735029

Yan WANG sub-Investigator

Role: CONTACT

11111230025@fudan.edu.cn

18121298388

Other Identifiers

FDRT-2024-157-3710

Identifier Type: -

Identifier Source: org_study_id