Clinical efficacy of ctDNA dynamics before and after total neoadjuvant treatment in locally adjuvant rectal cancer.

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0008155
• Lead Sponsor: Chonnam National University Hospital Hwasun Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 8 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Histologically confirmed loco-regional rectal adenocarcinoma (cT3-4,Nany)
Male and female participants >=18 and <=80 of age inclusive, at the time of signing the informed consent
Radiologically confirmed cT3, CRM positive or T4 or unresectable in rectal MRI(enhance)

Exclusion Criteria

Structurally bowel obstruction lesion or impending feature
bowel perforation or grade >= hemorrhage or bleeding event
History of distant metastatic lesions
Grade >=1 of CTC-AE
Uncontrolled significant cardiovascular disease or unstable angina or myocardial infarction or unstable arrhythmia or hepatitis or coagulopathy risk or psychosis prior to initiation of study treatment
Known allergy or hypersensitivity to fluoropyrimidine or platinum drugs or their excipients
Known DPD deficiency identified
Prior clinical study within 4 weeks prior to initiation of study treatment

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ctDNA, mrTRG on rectal MRI, patologic CR

Secondary Outcome Measures

Name	Time	Method
progression free survival, overall survival