Status:
NOT_YET_RECRUITING
An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer
Lead Sponsor:
Fudan University
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The study is designed to test the hypothesis that the clinical complete response (CCR) rate of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant chemoradiotherapy will incre...
Detailed Description
1. Primary objective: Evaluate the CCR rate of low rectal cancer using adaptive and optimized chemotherapy and radiotherapy strategies (all population and dMMR/MSI-H subgroup) 2. Secondary objecti...
Eligibility Criteria
Inclusion
- pathological confirmed adenocarcinoma
- clinical stage T2-4 and/or N+, inappropriate for local excision
- the distance from anal verge less than 5 cm, or considered inappropriate for anal preservation by surgeons.
- Strong desire to preserve the anus, able to receive close surveillance for at least 2 years after chemoradiotherapy.
- without distance metastases
- aged between 18 to 75 years old.
- performance status score: 0\~1
- UGT1A1\*28 6/6 or 6/7
- sign the inform consent
Exclusion
- pregnancy or breast-feeding women
- serious medical illness
- difficult to achieve complete response assessed by current evidence: the maximal diameter of tumor \>10cm; the maximal diameter of lateral lymph node \>2cm; baseline CEA\>=100; biopsy pathology confirmed signet ring cell carcinoma components; digital rectal examination found that the tumor is peri-narrowed.
- baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
- DPD deficiency
- UGT1A1\*28 7/7
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT04443543
Start Date
June 22 2020
End Date
December 31 2026
Last Update
June 30 2020
Active Locations (1)
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1
Fudan University Shanghai Cancer Cencer
Shanghai, Shanghai Municipality, China, 200032