Colon CancerPhase 2NCT06652412
CGA Guided Ultrafractionated RT and Systemic Treatment in Elderly or Frail Patients with Inoperable Localized CRC
A Phase 2 study testing Ultrafractionated RT and CGA Guided systemic treatment., data prospectively collected and Ultrafractionated Radiotherapy in people with Colon Cancer and Rectal Cancer, run by Fudan University.
Trial summary
This is a prospective, multicentre, cohort study. For cohort 1, experimental cohort, older or Frail patients with inoperable localized 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., data prospectively collected and Ultrafractionated Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 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;
- Pathologically confirmed Colorectal adenocarcinoma;
- any distance from anal verge;
- Clinical stage ≥T2 and/or N+, without distance metastases;
- refuse radical operation, physiologically or technically inoperable;
Show all 11Show fewer
- No previous radiotherapy in the same field；
- No chemotherapy prior to enrollment;
- 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 or thyroid carcinoma.
- 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≥90g/L; NEU ≥1.5×109/L; PLT ≥100×109/L; 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 Systemic Treatment in Elderly or Frail Patients with Inoperable Localized Colorectal Cancer
This is a prospective, multicentre, cohort study. For cohort 1, experimental cohort, older or Frail patients with inoperable localized 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 and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC.
For cohort 2, 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 complete response (CR, pathological complete response [pCR] plus clinical complete response [cCR]) rate. The secondary endpoints include the grade 3-4 acute adverse effects rate, anal preservation rate, survival etc.
Read the detailed description
This is a prospective, multicentre, cohort study. For cohort 1, experimental cohort, older or Frail patients with inoperable localized 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 and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC.
For cohort 2, 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 complete response (CR, pathological complete response [pCR] plus clinical complete response [cCR]) rate. The secondary endpoints include the grade 3-4 acute adverse effects rate, anal preservation rate, 1-year DFS rate, 1-year DSS rate, 1-year OS rate etc.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- Ultrafractionated RT and CGA Guided systemic treatment., data prospectively collected, Ultrafractionated Radiotherapy, Sintilimab, Fluorouracil
- 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 and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC.
data prospectively collectedOther
in cohort 2, 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.
Ultrafractionated RadiotherapyRadiation
1Fx every 3 or 4weeks
SintilimabDrug
200 mg q3w
FluorouracilDrug
5-Fluorouracil or capecitabine
RaltitrexedDrug
Raltitrexed
OxaliplatinDrug
Oxaliplatin
Irinotecan (CPT-11)Drug
irinotecan
| Study group | Role | What they receive |
|---|---|---|
| CGA cohort | Experimental | in cohort 1, all patients will receive Ultrafractionated RT, PD-1 antibody, and Comprehensive Geriatric Assessment (CGA) Guided systemic treatment.
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 and BSC; Fit patients will receive doublet chemotherapy and BSC. Receives: Drug: Ultrafractionated RT and CGA Guided systemic treatment.; Radiation: Ultrafractionated Radiotherapy; Drug: Sintilimab; Drug: Fluorouracil; Drug: Raltitrexed; Drug: Oxaliplatin; Drug: Irinotecan (CPT-11) |
| 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: Other: data prospectively collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR) rate
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of clinical complete response (cCR) with Watch \& Wait (W\&W) strategy.
Measured: 1 month after the surgery or the decision of W&W
Secondary outcomes (7)
Grade 3-4 adverse effects rate
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
Measured: From date of randomization until 3 months after the completion neoadjuvant therapy
1 year anal preservation rate
1 year anal preservation rate
Measured: From date of randomization until the date of or date of death from any cause, whichever came first, assessed up to 12 months.
health-related quality of life (HRQOL)
HRQOL assessed with validated European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) ColoRectal cancer (CR) with 29 items (C29) and with 30 items (C30). Multiple measurements and scores will be aggregated to arrive at one reported value. Scores at different time points after randomization will be compared to baseline scores.
Measured: baseline, and at 3, 6 and 12 months.
1 year disease free survival rate
Rate of 1 year disease free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
1 year local recurrence free survival rate
Rate of 1 year local recurrence free survival
Measured: From date of randomization until the date of first documented pelvic failure, assessed up to 12 months.
1 year Disease-specific survival rate
rate of 1 year Disease-specific survival
Measured: From date of randomization until the date of death from the specific disease, assessed up to 12 months.
1 year overall survival rate
Rate of 1 year overall survival
Measured: From date of randomization 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 posted22 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
- 124 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
- NCT06652412
- Sponsor's protocol ID
- FDRT-2024-137-3690
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 28 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 28 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 Systemic Treatment in Elderly or Frail Patients with Inoperable Localized Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06652412
- Acronym / sponsor ID
- FDRT-2024-137-3690
- Conditions
- Colon Cancer, Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 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
- 22 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, experimental cohort, older or Frail patients with inoperable localized 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 and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC.
For cohort 2, 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 complete response (CR, pathological complete response [pCR] plus clinical complete response [cCR]) rate. The secondary endpoints include the grade 3-4 acute adverse effects rate, anal preservation rate, survival etc.
Detailed description
This is a prospective, multicentre, cohort study. For cohort 1, experimental cohort, older or Frail patients with inoperable localized 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 and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC.
For cohort 2, 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 complete response (CR, pathological complete response [pCR] plus clinical complete response [cCR]) rate. The secondary endpoints include the grade 3-4 acute adverse effects rate, anal preservation rate, 1-year DFS rate, 1-year DSS rate, 1-year 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: Sintilimab, Drug: Fluorouracil, Drug: Raltitrexed, Drug: Oxaliplatin, Drug: Irinotecan (CPT-11)in cohort 1, all patients will receive Ultrafractionated RT, PD-1 antibody, and Comprehensive Geriatric Assessment (CGA) Guided systemic treatment. 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 and BSC; Fit patients will receive doublet chemotherapy and BSC. |
| external control cohort | Other | Other: data prospectively collectedexternal 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;
- Pathologically confirmed Colorectal adenocarcinoma;
- any distance from anal verge;
- Clinical stage ≥T2 and/or N+, without distance metastases;
Key exclusion criteria (8 listed)
- Known history of other malignancies within 3 years，except cured skin cancer, cervical cancer in situ or thyroid carcinoma.
- 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 and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC. | Drug | CGA cohort |
| data prospectively collectedin cohort 2, 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. | Other | external control cohort |
| Ultrafractionated Radiotherapy1Fx every 3 or 4weeks | Radiation | CGA cohort |
| Sintilimab200 mg q3w | Drug | CGA cohort |
| Fluorouracil5-Fluorouracil or capecitabine | Drug | CGA cohort |
| RaltitrexedRaltitrexed | Drug | CGA cohort |
| OxaliplatinOxaliplatin | Drug | CGA cohort |
| Irinotecan (CPT-11)irinotecan | Drug | CGA cohort |
Primary outcome
Complete response (CR) rate
Time frame: 1 month after the surgery or the decision of W&W
Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of clinical complete response (cCR) with Watch \& Wait (W\&W) strategy.
7 secondary outcomes
Grade 3-4 adverse effects rate
Time frame: From date of randomization until 3 months after the completion neoadjuvant therapy
1 year anal preservation rate
Time frame: From date of randomization until the date of or date of death from any cause, whichever came first, assessed up to 12 months.
health-related quality of life (HRQOL)
Time frame: baseline, and at 3, 6 and 12 months.
1 year disease free survival rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
1 year local recurrence free survival rate
Time frame: From date of randomization until the date of first documented pelvic failure, assessed up to 12 months.
1 year Disease-specific survival rate
Time frame: From date of randomization until the date of death from the specific disease, assessed up to 12 months.
1 year overall survival rate
Time frame: From date of randomization 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 28 Oct 2024.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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., data prospectively collected and Ultrafractionated Radiotherapy 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 28 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?
Complete response (CR) rate (time frame: 1 month after the surgery or the decision of W&W). 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 28 Oct 2024.