Colon CancerPhase 2NCT06665087
CGA Guided Ultrafractionated RT and First-line Systemic Treatment in Elderly or Frail Patients with MCRC
A Phase 2 study testing Ultrafractionated RT and CGA Guided systemic treatment., Ultrafractionated Radiotherapy and PD-1 antibody in people with Colon Cancer and Rectal Cancer, run by Fudan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- Ultrafractionated RT and CGA Guided systemic treatment., Ultrafractionated Radiotherapy and PD-1 antibody
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comprehensive Geriatric Assessment (CGA) Guided Ultrafractionated Radiotherapy and First-line Systemic Treatment in Elderly or Frail Patients with Metastatic Colorectal Cancer
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.
Read the 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.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- Ultrafractionated RT and CGA Guided systemic treatment., Ultrafractionated Radiotherapy, PD-1 antibody, Chemotherapy (Fluorouracil), Chemotherapy (Raltitrexed)
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Ultrafractionated RadiotherapyRadiation
1Fx every 3 or 4weeks
PD-1 antibodyDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Chemotherapy (Fluorouracil); Drug: Chemotherapy (Raltitrexed); Drug: Chemotherapy (Oxaliplatin); Drug: Chemotherapy (CPT-11); Drug: Targeted Therapy (anti-VEGF); Drug: Targeted Therapy (anti-EGFR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 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
Rate of chemotherapy, radiotherapy, targeted therapy, and immunotherapy related adverse events.
Measured: From the start of treatment until 3 months after the completion of therapy.
the Overall Response Rate (ORR)
the percentage of patients with a best overall response of complete response or partial response.
Measured: 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.
Measured: 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.
Measured: baseline, and at 3, 6 and 12 months.
1-year Disease-specific survival (DSS) rate
rate of 1 year Disease-specific survival
Measured: 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
Measured: From the start of treatment until the date of death from any cause, assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Zhang, Fudan University
- Investigators
- Zhen ZHANG Principal Investigator, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665087
- Sponsor's protocol ID
- FDRT-2024-157-3710
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Geriatric Assessment (CGA) Guided Ultrafractionated Radiotherapy and First-line Systemic Treatment in Elderly or Frail Patients with Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06665087
- Acronym / sponsor ID
- FDRT-2024-157-3710
- Conditions
- Colon Cancer, Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGA cohort | Experimental | 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)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 | 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 from real word, data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | CGA cohort |
| Ultrafractionated Radiotherapy1Fx every 3 or 4weeks | Radiation | CGA cohort |
| PD-1 antibodySintilimab | Drug | CGA cohort |
| Chemotherapy (Fluorouracil)5-Fluorouracil or capecitabine | Drug | CGA cohort, external control cohort |
| Chemotherapy (Raltitrexed)Raltitrexed | Drug | CGA cohort, external control cohort |
| Chemotherapy (Oxaliplatin)Oxaliplatin | Drug | CGA cohort, external control cohort |
| Chemotherapy (CPT-11)Irinotecan | Drug | CGA cohort, external control cohort |
| Targeted Therapy (anti-VEGF)anti-VEGF antibody | Drug | CGA cohort, external control cohort |
| Targeted Therapy (anti-EGFR)anti-EGFR antibody | Drug | CGA cohort, external control cohort |
Primary outcome
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
6 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhen ZHANG Principal Investigator principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ultrafractionated RT and CGA Guided systemic treatment., Ultrafractionated Radiotherapy and PD-1 antibody in people with Colon Cancer and Rectal Cancer, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhen ZHANG Principal Investigator (18801735029, zhen_zhang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.