CGA Guided Ultrafractionated RT and Systemic Treatment in Elderly or Frail Patients with Inoperable Localized CRC
Phase 2
Not yet recruiting
- Conditions
- Interventions
- Registration Number
- NCT06652412
- Lead Sponsor
- Fudan University
- Brief 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. All patients will receive Ultrafractionated RT and PD-1 antibody. Furthermore, CGA wil...
- 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 wil...
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 124
Inclusion Criteria
- ≥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;
- 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
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Exclusion Criteria
- 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CGA cohort Ultrafractionated RT and CGA Guided systemic treatment. 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. CGA cohort Ultrafractionated Radiotherapy 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. CGA cohort Sintilimab 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. CGA cohort Fluorouracil 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. CGA cohort Raltitrexed 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. CGA cohort Oxaliplatin 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. CGA cohort 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 data prospectively collected 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.
- Primary Outcome Measures
Name Time Method Complete response (CR) rate 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.
- Secondary Outcome Measures
Name Time Method Grade 3-4 adverse effects rate From date of randomization until 3 months after the completion neoadjuvant therapy Rate of chemotherapy, radiotherapy and immunotherapy related adverse events
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 anal preservation rate
health-related quality of life (HRQOL) 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 ba...
1 year disease free survival rate 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
1 year local recurrence free survival rate 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
1 year Disease-specific survival rate 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
1 year overall survival rate From date of randomization until the date of death from any cause, assessed up to 12 months. Rate of 1 year overall survival