A Prospective Cohort Study of Advanced Colorectal Cancer Treated With Oxaliplatin and Irinotecan.

Advanced Colorectal Cancer Clinical Trial

Official title:

A Multi-center、Prospective Cohort Study of Advanced Colorectal Cancer Treated With Oxaliplatin and Irinotecan.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05731336
• Other study ID #: SYU-2022
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: February 2023
• Source: Sun Yat-sen University
• Contact: Dongsheng Zhang, MD., phD.
• Phone: 86+020-87343795
• Email: zhangdsh[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this prospective observational study is to learn about the treatment decisions in advanced colorectal cancer treated with oxaliplatin and irinotecan. The main questions:1. learn about the efficacy and safety of immunotherapy or targeted drugs or other chemotherapy for patients treated with oxaliplatin and irinotecan（non-retreatment/rechallenge group，NR group）. 2. learn about the efficacy and safety of oxaliplatin or irinotecan for patients treated with oxaliplatin and irinotecan (retreatment/rechallenge group, RT/RC group). 3. compare the efficacy and safety of various treatment regimens for patients treated with oxaliplatin and irinotecan. This study will only collect the clinical data of patients, without any intervention, in the treatment services. All participants will be provided written informed consent as per the Declaration of Helsinki principles.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Phologically confirmed colorectal adenocarcinoma

2. Treated by oxaliplatin and irinotecan and discontinued due to progression or intolerable drug toxicity

3. ECOG 0-2

4. Predicted survival more than 3 months

5. Estimated by investigators that the main organ function is enough good to tolerate the next treatment plan.

6. Sign informed consent.

7. Agree to receive survival follow-up

Exclusion Criteria:

1. Previously exposed to regorafenib, furoquintinib, TAS-102, PD-1 inhibitors, or targeted drugs or immunotherapy for HER2 amplification, BRAF V600E mutation, and NTRK gene fusion.

2. Previously rechallenged or retreated by oxaliplatin or irinotecan after progression from chemotherapy regimens including oxaliplatin and irinotecan.

3. Participate in another interventional clinical study at the same time, unless in the follow-up stage of intervention study.

4. Proposed to use a treatment regimen containing regorafenib, furquintinib, and trifluridine, but has any problems obstacling oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction et al.

5. Disagree to take contraceptive measures during the study treatment period or within 6 months after the end of the study treatment period.

6. Has other primary malignant tumor history, unless non-melanoma skin cancer or lentigo maligna or carcinoma in situ with sufficient treatment and no disease recurrence.

7. Has the history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.

8. Has concomitant diseases that seriously endanger patient safety or affect patient completion of the study.

9. Has other problems that is not suitable for clinical research.

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival, PFS	PFS was calculated as the time from the date of treatment initiation to the date of disease progression or the last follow-up	Up to 12 months
Primary	Overall Survival, OS	OS was calculated as the time from the date of treatment initiation to the date of any cause of death, or the last follow-up.	Up to 24 months
Secondary	Objective response rate ,ORR	The ORR was defined as the percentage of patients performing a complete response (CR) or a partial response (PR) according to RECIST V1.1.	Up to 12 months
Secondary	Disease Control Rate,DCR	The ORR was defined as the percentage of patients performing a complete response (CR) or a partial response (PR) or a stable disease (SD) according to RECIST V1.1.	Up to 12 months
Secondary	Quality of life score	evaluated according to EORTC QLQ-C30 V3.0	Up to 24 months
Secondary	Comprehensive score of economic burden	evaluated according to COST-PROM	Up to 24 months
Secondary	Adverse events, AEs	evaluated by NCI-CTC AE V5.0	Up to 24 months