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

NCT ID: NCT06652412

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 124 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, 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.

Detailed Description

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.

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

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.

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 and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC.

Ultrafractionated Radiotherapy

Intervention Type: RADIATION

1Fx every 3 or 4weeks

Sintilimab

Intervention Type: DRUG

200 mg q3w

Fluorouracil

Intervention Type: DRUG

5-Fluorouracil or capecitabine

Raltitrexed

Intervention Type: DRUG

Raltitrexed

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin

Irinotecan (CPT-11)

Intervention Type: DRUG

irinotecan

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

data prospectively collected

Intervention Type: 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.

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 and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Ultrafractionated Radiotherapy

1Fx every 3 or 4weeks

Intervention Type: RADIATION

Sintilimab

200 mg q3w

Intervention Type: DRUG

Fluorouracil

5-Fluorouracil or capecitabine

Intervention Type: DRUG

Raltitrexed

Raltitrexed

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin

Intervention Type: DRUG

Irinotecan (CPT-11)

irinotecan

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. ≥70y, or, ≥60 and <70y but ECOG≥2;

2. male or female;

3. Pathologically confirmed Colorectal adenocarcinoma;

4. any distance from anal verge;

5. Clinical stage ≥T2 and/or N+, without distance metastases;

6. refuse radical operation, physiologically or technically inoperable;

7. No previous radiotherapy in the same field；

8. No chemotherapy prior to enrollment;

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 or thyroid carcinoma.

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≥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

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-2024-137-3690

Identifier Type: -

Identifier Source: org_study_id