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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3-4 adverse effects rate | Rate of chemotherapy, radiotherapy, targeted therapy, and immunotherapy related adverse events. | From the start of treatment until 3 months after the completion of therapy. |
| the Overall Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen ZHANG Principal Investigator | Contact | 18801735029 | zhen_zhang@fudan.edu.cn | |
| Yan WANG sub-Investigator | Contact | 18121298388 | 11111230025@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhen ZHANG Principal Investigator | Fudan University | Principal Investigator |
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|
| Ultrafractionated Radiotherapy | Radiation | 1Fx every 3 or 4weeks |
|
| PD-1 antibody | Drug | Sintilimab |
|
| Chemotherapy (Fluorouracil) | Drug | 5-Fluorouracil or capecitabine |
|
| Chemotherapy (Raltitrexed) | Drug | Raltitrexed |
|
| Chemotherapy (Oxaliplatin) | Drug | Oxaliplatin |
|
| Chemotherapy (CPT-11) | Drug | Irinotecan |
|
| Targeted Therapy (anti-VEGF) | Drug | anti-VEGF antibody |
|
| Targeted Therapy (anti-EGFR) | Drug | anti-EGFR antibody |
|
the percentage of patients with a best overall response of complete response or partial response.
| up to 1 year since the start of treatment. |
| health-related quality of life (HRQOL) | EORTC QLQ C30 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core with 30 items] will be filled by all patients. Scores at different time points after treatment will be compared to baseline scores. | baseline, and at 3, 6 and 12 months. |
| health-related quality of life (HRQOL) | EORTC QLQ CR29 [The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) ColoRectal cancer (CR) with 29 items] will be filled out by all patients. Scores at different time points after treatment will be compared to baseline scores. | baseline, and at 3, 6 and 12 months. |
| 1-year Disease-specific survival (DSS) rate | rate of 1 year Disease-specific survival | 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 | rate of 1 year overall survival | From the start of treatment until the date of death from any cause, assessed up to 12 months. |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
| D004358 | Drug Therapy |
| D005472 | Fluorouracil |
| C068874 | raltitrexed |
| D000077150 | Oxaliplatin |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
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