CGA Guided Ultrafractionated RT and Systemic Treatment in Elderly or Frail Patients with Inoperable Localized CRC

October 24, 2024 updated by: Zhen Zhang, Fudan University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥70y, or, ≥60 and <70y but ECOG≥2;
  2. male or female;
  3. Pathologically confirmed Colorectal adenocarcinoma;
  4. any distance from anal verge;
  5. Clinical stage ≥T2 and/or N+, without distance metastases;
  6. refuse radical operation, physiologically or technically inoperable;
  7. No previous radiotherapy in the same field；
  8. No chemotherapy prior to enrollment;
  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 or thyroid carcinoma.
  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≥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
  8. Individuals allergic to any drug component of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CGA cohort

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.
Drug: Oxaliplatin
Oxaliplatin
Drug: 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.
Radiation: Ultrafractionated Radiotherapy
1Fx every 3 or 4weeks
Drug: Sintilimab
200 mg q3w
Drug: Fluorouracil
5-Fluorouracil or capecitabine
Drug: Irinotecan (CPT-11)
irinotecan
Drug: Raltitrexed
Raltitrexed
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.
Other: data prospectively collected
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month after the surgery or the decision of W&W

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade 3-4 adverse effects rate
Time Frame: From date of randomization until 3 months after the completion neoadjuvant therapy
Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
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.
1 year anal preservation rate
From date of randomization until the date of or date of death from any cause, whichever came first, assessed up to 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.
Rate of 1 year disease free survival
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.
Rate of 1 year local recurrence free survival
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.
rate of 1 year Disease-specific survival
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.
Rate of 1 year overall survival
From date of randomization until the date of death from any cause, assessed up to 12 months.
health-related quality of life (HRQOL)
Time Frame: baseline, and at 3, 6 and 12 months.
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.
baseline, and at 3, 6 and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Zhen ZHANG Principal Investigator, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDRT-2024-137-3690

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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