Status:
RECRUITING
Total Neoadjuvant Therapy in Rectal Cancer
Lead Sponsor:
National Cheng-Kung University Hospital
Conditions:
Rectal Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospecti...
Detailed Description
This is a single center, single-arm, open-label, phase II study to investigate the efficacy and toxicities of total neoadjuvant therapy in patients with middle or lower rectal cancer. This study is pl...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed diagnosis of adenocarcinoma of the rectum;
- Tumors located at mid or low rectum (distal extension less than 10 cm from the anal verge);
- Clinical stage II or III (T3/4 and/or N+; no distant metastasis);
- No prior chemotherapy, radiotherapy or surgery for rectal cancer;
- Age ≥20;
- ECOG 0-1;
- Adequate organ function, including followings:
- ANC ≥1,500/μL; Hb ≥8.0 gm/dL; Platelet 100,000/mm3; Total bilirubin ≤1.5x upper normal limit; AST ≤3x upper normal limit; ALT ≤3x upper normal limit; Creatinine ≤1.5x upper normal limit;
- Ability to understand and the willingness to sing a written informed consent.
- Exclusion criteria
- Recurrent rectal cancer;
- Patients who have concomitant malignancies, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. Subjects who have prior malignancies and have been disease-free for more than 5 years can be enrolled;
- Patients who have received prior pelvic radiotherapy;
- Patients with active infection requiring intravenous antibiotic treatment;
- Patients with a history of any arterial thrombotic event within the past 6 months, including unstable angina, myocardial infarction (MI) or cerebrovascular accident (CVA), New York Hear Association (NYHA) grade II or greater congestive heart failure, or uncontrolled cardiac arrhythmia;
- Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into this study;
- Women who are pregnant or breastfeeding. Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period;
- Patients receiving other anticancer or experimental therapy;
- Known DPD deficiency or hypersensitivity to oxaliplatin;
- Any contraindications to MRI.
Exclusion
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 16 2030
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06162650
Start Date
November 16 2023
End Date
November 16 2030
Last Update
December 8 2023
Active Locations (1)
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1
National Cheng Kung University Hospital
Tainan, Taiwan, 704