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

NCT06665087 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: FDRT-2024-157-3710
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colon Cancer; Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes (6)

• Grade 3-4 adverse effects rate

  From the start of treatment until 3 months after the completion of therapy.

• the Overall Response Rate (ORR)

  up to 1 year since the start of treatment.

• health-related quality of life (HRQOL)

  baseline, and at 3, 6 and 12 months.

• health-related quality of life (HRQOL)

  baseline, and at 3, 6 and 12 months.

• 1-year Disease-specific survival (DSS) rate

  From the start of treatment until the date of death from the specific disease, assessed up to 12 months.

Study Arms (2)

CGA cohort

EXPERIMENTAL

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.

Drug: Ultrafractionated RT and CGA Guided systemic treatment.; Radiation: Ultrafractionated Radiotherapy; Drug: PD-1 antibody; Drug: Chemotherapy (Fluorouracil); Drug: Chemotherapy (Raltitrexed); Drug: Chemotherapy (Oxaliplatin); Drug: Chemotherapy (CPT-11); Drug: Targeted Therapy (anti-VEGF); Drug: Targeted Therapy (anti-EGFR)

external control cohort

OTHER

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.

Drug: Chemotherapy (Fluorouracil); Drug: Chemotherapy (Raltitrexed); Drug: Chemotherapy (Oxaliplatin); Drug: Chemotherapy (CPT-11); Drug: Targeted Therapy (anti-VEGF); Drug: Targeted Therapy (anti-EGFR)

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

CGA cohort

Ultrafractionated Radiotherapy RADIATION

1Fx every 3 or 4weeks

CGA cohort

PD-1 antibody DRUG

Sintilimab

CGA cohort

Chemotherapy (Fluorouracil) DRUG

5-Fluorouracil or capecitabine

CGA cohort; external control cohort

Chemotherapy (Raltitrexed) DRUG

Raltitrexed

CGA cohort; external control cohort

Chemotherapy (Oxaliplatin) DRUG

Oxaliplatin

CGA cohort; external control cohort

Chemotherapy (CPT-11) DRUG

Irinotecan

CGA cohort; external control cohort

Targeted Therapy (anti-VEGF) DRUG

anti-VEGF antibody

CGA cohort; external control cohort

Targeted Therapy (anti-EGFR) DRUG

anti-EGFR antibody

CGA cohort; external control cohort

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥70y, or, ≥60 and \<70y but ECOG≥2;
• male or female;
• metastatic colorectal cancer;
• at least one measurable leasion;
• the primary lesion could be 1)previously resected, or 2) not resected or recurred, and not been previously irradiated;
• no more than 10 lesions, and all the lesions could be safely irradiated.
• life expectancy is more than 3 months;
• no previous standard first-line anti-cancer treatment(including 5-FU/ Capecitabine/Raltitrexed, oxaliplatin, or irinotecan), or more than 6 months after perioperative chemotherapy;
• No immunotherapy prior to enrollment;
• With good compliance during the study;
• Signed written informed consent.

You may not qualify if:

• Known history of other malignancies within 3 years，except cured skin cancer, cervical cancer in situ, thyroid carcinoma, or clinical controlled prostate cancer;
• 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;
• 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;
• Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy;
• Individuals with autoimmune diseases;
• Individuals with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
• 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;
• Individuals allergic to any drug component of the study.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

spartalizumab; Drug Therapy; Fluorouracil; raltitrexed; Oxaliplatin; Irinotecan

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids

Study Officials

• Zhen ZHANG Principal Investigator

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen ZHANG Principal Investigator

CONTACT

18801735029; zhen_zhang@fudan.edu.cn

Yan WANG sub-Investigator

CONTACT

18121298388; 11111230025@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 30, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: October 30, 2024

Record last verified: 2024-10