Not yet recruitingNCT06665087Updated Oct 30, 2024

CGA Guided Ultrafractionated RT and First-line Systemic Treatment in Elderly or Frail Patients with MCRC

A Phase 2 interventional study of Ultrafractionated RT and CGA Guided systemic treatment. and Ultrafractionated Radiotherapy in Colon Cancer and Rectal Cancer, sponsored by Fudan University. Not yet recruiting. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-10-30.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 110
Allocation: Non-randomized
Ages: 60 Years and older
Sex: All

Study 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.

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.

Conditions studied

Colon Cancer
Rectal Cancer

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In context

Colonic Neoplasms

1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.

This study's planned enrollment of 110 is above the median of 89 across 1,067 interventional studies indexed under Colonic Neoplasms.

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Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 60 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 110 participants (estimated)

Study arms

Experimental
CGA cohort
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.
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)
Other
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.
Drug: Chemotherapy (Fluorouracil) · Drug: Chemotherapy (Raltitrexed) · Drug: Chemotherapy (Oxaliplatin) · Drug: Chemotherapy (CPT-11) · Drug: Targeted Therapy (anti-VEGF) · Drug: Targeted Therapy (anti-EGFR)

Interventions

DrugUltrafractionated 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.
RadiationUltrafractionated Radiotherapy
1Fx every 3 or 4weeks
DrugPD-1 antibody
Sintilimab
DrugChemotherapy (Fluorouracil)
5-Fluorouracil or capecitabine
DrugChemotherapy (Raltitrexed)
Raltitrexed
DrugChemotherapy (Oxaliplatin)
Oxaliplatin
DrugChemotherapy (CPT-11)
Irinotecan
DrugTargeted Therapy (anti-VEGF)
anti-VEGF antibody
DrugTargeted Therapy (anti-EGFR)
anti-EGFR antibody

What researchers measure

Primary outcomes

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 outcomes

Grade 3-4 adverse effects rate
Rate of chemotherapy, radiotherapy, targeted therapy, and immunotherapy related adverse events.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, and at 3, 6 and 12 months.
1-year Disease-specific survival (DSS) rate
rate of 1 year Disease-specific survival
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
rate of 1 year overall survival
Time frame: From the start of treatment until the date of death from any cause, assessed up to 12 months.

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2024; primary completion for Nov 2027, 36 months later.

Of 75 non-industry phase 2 interventional studies under Colonic Neoplasms, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 62. This study's planned 36 months is below that.

Counting every sponsor, half of 84 studies reached it within 43 months; a quarter within 29 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 24, 2024
First posted: Oct 30, 2024
StartEst.: Nov 2024
Primary completionEst.: Nov 2027
CompletionEst.: Nov 2028
Last update: Oct 30, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06665087
Lead sponsor: Fudan University
Responsible party: Zhen Zhang (Principal Investigator, Fudan University) — Principal investigator
First posted: Oct 30, 2024
Start date: Nov 2024 (estimated)
Primary completion: Nov 2027 (estimated)
Completion: Nov 2028 (estimated)
Last update: Oct 30, 2024

Study contacts

Zhen ZHANG Principal Investigator

Contact

zhen_zhang@fudan.edu.cn

18801735029

Yan WANG sub-Investigator

Contact

11111230025@fudan.edu.cn

18121298388

Zhen ZHANG Principal Investigator

principal investigator · Fudan University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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