Trial Title:
CGA Guided Ultrafractionated RT and First-line Systemic Treatment in Elderly or Frail Patients with MCRC
NCT ID:
NCT06665087
Condition:
Colon Cancer
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Colonic Neoplasms
Oxaliplatin
Fluorouracil
Raltitrexed
Antibodies
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ultrafractionated RT and CGA Guided systemic treatment.
Description:
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.
Arm group label:
CGA cohort
Intervention type:
Radiation
Intervention name:
Ultrafractionated Radiotherapy
Description:
1Fx every 3 or 4weeks
Arm group label:
CGA cohort
Intervention type:
Drug
Intervention name:
PD-1 antibody
Description:
Sintilimab
Arm group label:
CGA cohort
Intervention type:
Drug
Intervention name:
Chemotherapy (Fluorouracil)
Description:
5-Fluorouracil or capecitabine
Arm group label:
CGA cohort
Arm group label:
external control cohort
Intervention type:
Drug
Intervention name:
Chemotherapy (Raltitrexed)
Description:
Raltitrexed
Arm group label:
CGA cohort
Arm group label:
external control cohort
Intervention type:
Drug
Intervention name:
Chemotherapy (Oxaliplatin)
Description:
Oxaliplatin
Arm group label:
CGA cohort
Arm group label:
external control cohort
Intervention type:
Drug
Intervention name:
Chemotherapy (CPT-11)
Description:
Irinotecan
Arm group label:
CGA cohort
Arm group label:
external control cohort
Intervention type:
Drug
Intervention name:
Targeted Therapy (anti-VEGF)
Description:
anti-VEGF antibody
Arm group label:
CGA cohort
Arm group label:
external control cohort
Intervention type:
Drug
Intervention name:
Targeted Therapy (anti-EGFR)
Description:
anti-EGFR antibody
Arm group label:
CGA cohort
Arm group label:
external control cohort
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.
Criteria for 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.
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 2024
Completion date:
November 2028
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06665087
