CGA Guided Ultrafractionated RT and First-line Systemic Treatment in Elderly or Frail Patients with MCRC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrafractionated RT and CGA Guided systemic treatment., Ultrafractionated Radiotherapy, PD-1 antibody, Chemotherapy (Fluorouracil).
- Who it may be relevant to
- Registry conditions: Colon Cancer, Rectal Cancer. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comprehensive Geriatric Assessment (CGA) Guided Ultrafractionated Radiotherapy and First-line Systemic Treatment in Elderly or Frail Patients with Metastatic Colorectal Cancer
Overview
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.
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
Primary outcome measures
- Progression Free Survival [Time frame: 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 outcome measures (6)
- Grade 3-4 adverse effects rate [Time frame: From the start of treatment until 3 months after the completion of therapy.]
- the Overall Response Rate (ORR) [Time frame: up to 1 year since the start of treatment.]
- health-related quality of life (HRQOL) [Time frame: baseline, and at 3, 6 and 12 months.]
- health-related quality of life (HRQOL) [Time frame: baseline, and at 3, 6 and 12 months.]
- 1-year Disease-specific survival (DSS) rate [Time frame: From the start of treatment until the date of death from the specific disease, assessed up to 12 months.]
- 1-year overall survival (OS) rate [Time frame: From the start of treatment until the date of death from any cause, assessed up to 12 months.]
Eligibility criteria
Inclusion criteria
- ≥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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06665087 · FDRT-2024-157-3710